Identity
- Trade Name
- Lighted Forceps EUDAMEDReplacement Forceps without Light Source FDA UDI
- Generic Name
- ENT foreign body extraction forceps FDA UDI
- Device Name
- Lighted Forceps EUDAMEDReplacement Forceps FDA UDI
- Model / Reference
- 2775 EUDAMEDFDA UDI
- Description
- Replacement Forceps FDA UDI
Identifiers
- Catalog Number
- 2775 FDA UDI
- Primary DI / UDI-DI
- 00859911004719 EUDAMEDFDA UDI
- Basic UDI-DI
- 859911004LightedForcep87 EUDAMED
- Unit of Use DI
- 10859911004716 EUDAMED
- FDA Product Code
- KAE FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- ENT foreign body extraction forceps FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
Lighted Forceps by Bionix, LLC — 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 | 859911004LightedForcep87 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionix LLC
- EUDAMED SRN
- US-MF-000020408
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 98aa025d-f069-4e07-80fd-870359c2da49 61 fields · synced Jun 19, 2026
- FDA UDI d3a1317d-613c-4afd-a8fb-b0ba843c295f 35 fields · synced May 29, 2026