Identity
- Trade Name
- Ear Curette - Jobson Horne Probe EUDAMEDJobson Horne Probe - Sterile FDA UDI
- Generic Name
- Endaural surgical curette, single-use FDA UDI
- Device Name
- Ear Curette - Jobson Horne Probe EUDAMED
- Model / Reference
- NZ3431-20S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421901970468 EUDAMEDFDA UDI
- Basic UDI-DI
- 9421905187EarCuretBR EUDAMED
- FDA Product Code
- JYG FDA UDI
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endaural surgical curette, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 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
Ear Curette - Jobson Horne Probe 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 | 9421905187EarCuretBR | 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 09a57bcd-9763-462b-af2d-ce0269eaa74b 61 fields · synced Jun 17, 2026
- FDA UDI ea7ceaaf-ee64-402e-95b9-92b9d3758dcd 32 fields · synced May 29, 2026