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Myringotomy Kit, with 7mm jaw micro ear forceps
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NZ3248B-5Model NZ3246-5
Identity
- Trade Name
- Myringotomy Kit, with 7mm jaw micro ear forceps EUDAMEDAdept Medical Myringotomy Kit 7mm Jaw Forceps FDA UDI
- Generic Name
- ENT surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Myringotomy Kit – no micro ear forceps EUDAMED
- Model / Reference
- NZ3246-5 EUDAMEDNZ3248B-5 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- NZ3248B-5 FDA UDI
- Primary DI / UDI-DI
- 09421902825750 EUDAMEDFDA UDI
- Basic UDI-DI
- 9421905187MyrinKit28 EUDAMED
- FDA Product Code
- KDD FDA UDI
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- ENT surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Myringotomy Kit, with 7mm jaw micro ear forceps by Adept Medical Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 9421905187MyrinKit28 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- EUDAMED SRN
- NZ-MF-000003374
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED e414a1e8-12ee-49b2-8ce9-70ee1b401677 61 fields · synced Jun 19, 2026
- FDA UDI 7017f960-9d42-4f47-80e5-dc0c14449482 33 fields · synced May 30, 2026