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Most Asked Questions
What types of ENT products does EON Meditech manufacture?
EON Meditech Australia manufactures a comprehensive range of ENT medical devices and surgical solutions designed to support ear, nose, and throat procedures across clinical, hospital, and specialist environments. Our product portfolio includes solutions in otology, rhinology, laryngology, ENT instruments, PVA dressings, and surgical support products. These products are developed to assist healthcare professionals with diagnosis, treatment, post-operative care, and patient recovery while maintaining high standards of quality, safety, and clinical performance.
How do I place an order with EON Meditech?
You can place an order through multiple channels:
- Online: Add products to your cart on our website and complete checkout, or click "Request a Quote" for institutional pricing
- Email: Send your product list with quantities to info@eonmeditech.com.au
- Phone: Call our sales team at +61 410 737 246 (Mon–Sat, 9AM – 6PM AEST)
- Purchase Order: Registered institutional accounts can send POs directly to our procurement team
For first-time institutional buyers, we recommend calling to set up an account with preferential pricing and dedicated support.
Which countries do you currently export to?
EON Meditech exports to 15+ countries across the following regions:
- South Asia: Bangladesh, Sri Lanka, Nepal, Pakistan
- Middle East: UAE, Saudi Arabia, Kuwait, Oman, Bahrain
- Africa: Kenya, Tanzania, Nigeria, Egypt, South Africa, Ghana
- South East Asia: Myanmar, Cambodia, Philippines, Vietnam
- Oceania: Australia, New Zealand
- United States: Select markets via regional distributors
- Europe: Select CE-marked products via authorized importers
If your country is not listed, contact our exports team, we evaluate new markets regularly.
Are the ear ventilation tubes single-use only?
Yes. All EON Meditech ear ventilation tubes (Shepard, Shah, Collar Button, Donaldson, etc.) and all implantable prostheses are single-use sterile devices. They must not be resterilized, reprocessed, or reused under any circumstances.
Reuse of single-use sterile devices may result in infection, device failure, or patient harm, and voids all product liability. This is consistent with EU MDR 2017/745 and CDSCO guidelines for single-use medical devices.
What regulatory certifications does EON Meditech hold?
EON Meditech maintains the following active certifications:
- EN ISO 13485:2016 — Medical Devices Quality Management System (certified by accredited CB)
- CE Marking — Applicable products conform to EU Medical Device Directive (MDD) / Regulation (EU) 2017/745 (MDR) via authorised EU Representative
- CDSCO Registration — All products are registered with India's Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017
- GMP Compliance — Manufacturing facility is GMP-compliant and subject to periodic inspections
otology
What materials are used in your otology products?
What sizes are available for ear ventilation tubes?
EON Meditech Australia manufactures the following ventilation tube types with the corresponding size ranges:
- Shepard Grommet: Inner diameter 1.14 mm, outer diameter 3.9 mm, standard for short-term drainage
- Shah & Mini Shah: Flanged design for longer retention; available in standard and mini variants
- Collar Button: T-tube design for long-term ventilation; shaft lengths 1.5–2.5 mm
- Donaldson Tube: For atelectatic ears; standard outer flange 4.5 mm
All tubes are made from medical-grade fluoroplastic (PTFE/Silicone) and supplied sterile.
PVA Dressings & Sponges
What makes BACILK PVA dressings different from standard nasal dressings?
BACILK PVA dressings use a proprietary double-compressed open-cell PVA (Polyvinyl Alcohol) structure that expands uniformly on contact with fluid. Key differences from standard gauze or foam dressings include:
- Hydrophilic micro-porous surface enabling smooth insertion in compressed state and atraumatic removal post-expansion
- Superior exudate absorption while maintaining a moist wound environment
- Non-allergic, non-cytotoxic, biocompatible, no latex or animal-derived materials
- Does not shred when trimmed; maintains shape integrity under surgical cutting
What is the shelf life of absorbable gelatin sponges?
EON Meditech Australia absorbable gelatin sponges have a shelf life of 3 years from the date of manufacture when stored under recommended conditions (below 30°C, away from direct sunlight, in a dry environment).
In the body, the sponge is fully absorbed within 4–6 weeks, depending on the surgical site and patient physiology. Always check the expiry date on the outer label before use.
ENT Instruments & Systems
Are the ENT instruments autoclavable?
Yes. All EON Meditech Australia stainless steel ENT instruments (curette sets, myringotomy knives, specula, suction tubes) are designed and validated for steam autoclave sterilization at 134°C / 273°F for 3 minutes (or 121°C for 15 minutes) per ISO 17665-1.
Instruments should be cleaned, inspected for damage, and assembled correctly before each sterilization cycle. Refer to the instrument-specific IFU for full reprocessing instructions.
Placing Orders
How do I place an order with EON Meditech?
You can place an order through multiple channels:
- Online: Add products to your cart on our website and complete checkout, or click "Request a Quote" for institutional pricing
- Email: Send your product list with quantities to info@eonmeditech.com.au
- Phone: Call our sales team at +61 410 737 246 (Mon–Sat, 9AM – 6PM AEST)
- Purchase Order: Registered institutional accounts can send POs directly to our procurement team
For first-time institutional buyers, we recommend calling to set up an account with preferential pricing and dedicated support.
What is the minimum order quantity (MOQ)?
MOQ varies by product category:
- Implants: 10 unit (single sterile unit), no minimum for individual orders
- Ear Ventilation Tubes: Box of 10 units minimum
- PVA Dressings: Pack of 10 minimum
- ENT Instruments: 1 set minimum
- Bulk/Institutional orders: Custom MOQ, contact sales for volume pricing tiers
Can I request a sample before placing a large order?
Yes, sample kits are available for qualified healthcare institutions and verified distributors. To request samples:
- You must provide institutional affiliation or distributor credentials
- Sample kits typically include 2–3 units per product line
- Shipping charges apply for samples (may be waived for large follow-on orders)
- Sterile single-use samples cannot be returned once dispatched
Contact info@eonmeditech.com.au with your requirement and credentials.
Pricing & Payment
What payment methods do you accept?
EON Meditech accepts the following payment methods:
- Bank Transfer (NEFT/RTGS/IMPS): Preferred for institutional orders
- International Wire Transfer (SWIFT): For export orders
- Cheque: For registered institutional accounts in India
- Online Payment: Credit/Debit card and Shop Pay through our website checkout
Credit terms (net 30/60 days) are available for pre-approved institutional accounts. Contact our finance team for details.
Do you offer discounts for bulk or institutional purchases?
Yes. We offer tiered pricing for volume orders:
- Tier 1 (50–200 units): ~8–12% discount on catalogue price
- Tier 2 (201–500 units): ~15–20% discount
- Tier 3 (500+ units / Annual contracts): Custom pricing, negotiated with our commercial team
Hospitals, ENT departments, and registered distributors qualify for institutional accounts with additional benefits including priority dispatch and dedicated account management.
Domestic Shipping
What are your standard dispatch and delivery timelines within Australia?
For domestic orders within Australia:
- Standard dispatch: 2–3 business days from order confirmation and payment receipt
- Priority dispatch (for urgent surgical orders): Same day or next business day, contact us to activate
- Delivery timelines: 3–7 business days depending on destination; metro cities typically 2–4 days
All sterile products are shipped in tamper-evident, damage-resistant packaging. A tracking number is provided by email upon dispatch.
How are sterile implants packaged for shipping?
All sterile implants are:
- Double-sealed in sterile barrier packaging (per ISO 11607)
- Placed in rigid protective outer cartons with inner cushioning to prevent impact damage
- Labelled with product name, lot number, expiry date, sterilization method, and IFU reference
- Temperature-stable, no cold chain required for standard implants and instruments
If packaging integrity is compromised upon receipt, do not use the product, contact us immediately for a replacement.
International Export
Which countries do you currently export to?
EON Meditech exports to 15+ countries across the following regions:
- South Asia: Bangladesh, Sri Lanka, Nepal, Pakistan
- Middle East: UAE, Saudi Arabia, Kuwait, Oman, Bahrain
- Africa: Kenya, Tanzania, Nigeria, Egypt, South Africa, Ghana
- South East Asia: Myanmar, Cambodia, Philippines, Vietnam
- Oceania: Australia, New Zealand
- United States: Select markets via regional distributors
- Europe: Select CE-marked products via authorised importers
If your country is not listed, contact our exports team, we evaluate new markets regularly.
What export documentation do you provide with international orders?
Standard export documentation includes:
- Commercial Invoice and Packing List
- Certificate of Origin (COO)
- Free Sale Certificate (FSC) issued by CDSCO
- CE Certificate (for applicable products)
- EN ISO 13485 Certificate of Conformity
- Product-specific IFU and sterilization declarations
Additional documents (e.g., MSDS, regulatory dossier for import registration) can be provided upon request. We recommend contacting us 2–3 weeks before your required delivery date for complex export orders.
Surgical Use & Instructions
Where can I download the Instructions for Use (IFU) for a specific product?
IFU booklets are included inside our library. Digital copies can be downloaded from our Technical Documentation Library on this website.
You can search by product name, catalogue code, or lot number. If you cannot find a specific IFU, email info@eonmeditech.com.au with the product code and we will send it within 1 business day.
Are the ear ventilation tubes single-use only?
Yes. All EON Meditech Australia ear ventilation tubes (Shepard, Shah, Collar Button, Donaldson, etc.) and all implantable prostheses are single-use sterile devices. They must not be resterilized, reprocessed, or reused under any circumstances.
Reuse of single-use sterile devices may result in infection, device failure, or patient harm, and voids all product liability. This is consistent with EU MDR 2017/745 and CDSCO guidelines for single-use medical devices.
How should I report an adverse event or device concern?
If you observe or suspect a device-related adverse event, malfunction, or labelling concern:
- Immediately: Preserve the device, packaging, and lot number, do not discard
- Contact EON Meditech: Email info@eonmeditech.com.au or call +61 410 737 246 with details of the incident
- Regulatory reporting: In India, serious adverse events with medical devices must be reported to CDSCO's MedTech vigilance portal. In the EU, report to your national Competent Authority
EON Meditech Australia maintains a Corrective and Preventive Action (CAPA) process and will investigate all reported events within 30 days.
Sterilization & Storage
What sterilization method is used for EON Meditech implants?
Most implantable products are sterilized using Ethylene Oxide (EO) gas sterilization per ISO 11135, performed at a validated third-party sterilization facility.
Gelatin sponges are gamma-irradiation sterilized. PVA dressings use EO sterilization. The sterilization method is indicated on each product label. Shelf life is typically 3–5 years from manufacture date.
Certifications & Compliance
What regulatory certifications does EON Meditech hold?
EON Meditech maintains the following active certifications:
- EN ISO 13485:2016, Medical Devices Quality Management System (certified by accredited CB)
- CE Marking, Applicable products conform to EU Medical Device Directive (MDD) / Regulation (EU) 2017/745 (MDR) via authorised EU Representative
- CDSCO Registration, All products are registered with India's Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017
- GMP Compliance, Manufacturing facility is GMP-compliant and subject to periodic inspections
How can I obtain a Free Sale Certificate (FSC) or Certificate of Origin?
Free Sale Certificates are issued by CDSCO on application by the manufacturer. EON Meditech can provide FSCs for products registered with CDSCO as part of your import dossier.
To request an FSC or COO for your import registration process:
- Email info@eonmeditech.com.au with the product list, destination country, and regulatory authority requirements
- Allow 5–7 business days for FSC processing (CDSCO timelines may vary)
- COO is issued per shipment and included in export documentation
Can I download ISO and CE certificates from your website?
Yes. Current certificates are available in our Regulatory Documents Library. Available for download:
- EN ISO 13485 Certificate (current scope and expiry date)
- CE Declaration of Conformity (per product family)
- CDSCO Registration Certificates
- GMP Compliance Declaration
If you require a notarised or apostilled copy for regulatory submission, contact our compliance team. Certificates are updated annually or upon renewal.
Becoming a Distributor
How can I become an authorised distributor for EON Meditech?
We welcome distribution enquiries from qualified medical device distributors globally. The process:
- Step 1: Submit a distributor application via our partnership enquiry form or email info@eonmeditech.com.au with your company profile, territory, and current portfolio
- Step 2: Our exports team evaluates the application, typical turnaround 5–7 business days
- Step 3: Introductory call/meeting to discuss territory exclusivity, MOQs, pricing tiers, and support structure
- Step 4: Distribution Agreement signed; initial stocking order dispatched
We prefer distributors with existing medical device experience and regulatory knowledge of their local market.
Do you offer exclusive distribution rights by territory?
EON Meditech offers exclusive territory agreements to qualified distributors who meet annual volume commitments and fulfill active market development obligations.
Exclusivity terms, minimum purchase commitments, and territory definitions are negotiated individually based on market size and distributor capacity. Non-exclusive arrangements are also available for distributors in the evaluation phase.
What marketing and regulatory support do you provide to distributors?
Registered EON Meditech Australia distributors receive:
- Product catalogues, brochures, and digital assets in English (other languages on request)
- Technical product training (on-site or virtual)
- Regulatory dossiers, FSCs, CE declarations, and IFU translations for import registration
- Co-branded marketing materials for conference participation
- Access to a dedicated distributor portal with real-time stock availability and order tracking
- Periodic clinical training webinars with our in-house surgical advisors
Understanding ENT Surgery
What is tympanoplasty and when is it recommended?
Tympanoplasty is a surgical procedure to repair a perforated (torn) eardrum (tympanic membrane) and reconstruct the middle ear bones (ossicles) if damaged. It is recommended when:
- There is a persistent hole in the eardrum causing hearing loss or recurrent ear infections
- Chronic otitis media (middle ear infection) has damaged the ossicular chain
- Cholesteatoma (an abnormal skin growth) requires removal and reconstruction
EON Meditech's titanium prostheses (TORP/PORP) are used by ENT surgeons during tympanoplasty to restore the hearing pathway. Ask your ENT surgeon whether you are a candidate for ossicular reconstruction.
How can I find an ENT surgeon who uses EON Meditech implants?
EON Meditech implants are used by ENT surgeons across India and in 15+ countries. To find a surgeon:
- Ask your referring doctor to recommend a specialist ENT surgeon experienced in middle ear surgery
- Contact EON Meditech at info@eonmeditech.com.au, we can connect you with surgeons in your region who use our products
- Look for ENT surgeons affiliated with major hospitals (Apollo, Fortis, Manipal, AIIMS, etc.) who regularly perform tympanoplasty and stapedectomy
What should I expect after ear implant surgery?
Recovery after middle ear implant surgery (tympanoplasty) typically involves:
- First 1–2 weeks: Ear packing in place; avoid water entering the ear; some discomfort, mild dizziness, or tinnitus is normal
- 2–6 weeks: Packing removed by surgeon; hearing may begin to improve gradually
- 3–6 months: Full hearing assessment; implant fully integrated
Follow your surgeon's specific post-operative instructions regarding activity restrictions, bathing, air travel, and follow-up visits. Contact your surgeon immediately if you experience sudden severe pain, fever, or significant hearing deterioration after surgery.
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info@eonmeditech.com.au
+61 410 737 246
81a Eggleton Street, Blacktown, NSW 2148, AU