Identity
- Trade Name
- Ear Specula - 10mm EUDAMEDEar Specula - 10mm Non-Sterile FDA UDI
- Generic Name
- Self-retaining ear speculum FDA UDI
- Device Name
- Ear Specula - 10mm EUDAMED
- Model / Reference
- NZ3235-100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421902825866 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190282586NZ3235-100XY EUDAMED
- Direct Marketing DI
- 09421902825866 EUDAMED
- FDA Product Code
- EPY FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Self-retaining ear speculum FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.1800 FDA UDI
- Market of Registration
- Estonia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ear Specula - 10mm by Adept Medical Ltd — Class I — 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 | 942190282586NZ3235-100XY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 bdfb2ee6-d78f-436b-9e70-f983ba5ed2d7 61 fields · synced Jul 29, 2026
- FDA UDI ccbf908f-3b0a-474f-bfa0-d3085dde7c31 32 fields · synced May 30, 2026