Identity
- Trade Name
- Lighted Ear Curette EUDAMEDLighted WaveCurette™ Clinic Pack FDA UDI
- Generic Name
- ENT illuminating foreign body extraction set FDA UDI
- Device Name
- Lighted Curettes EUDAMEDClinic Pack: Lighted Wave Curette FDA UDI
- Model / Reference
- 2203 EUDAMEDFDA UDI
- Description
- Clinic Pack: Lighted Wave Curette FDA UDI
Identifiers
- Catalog Number
- 2203 FDA UDI
- Primary DI / UDI-DI
- 00859911004634 EUDAMEDFDA UDI
- Basic UDI-DI
- 859911004LightedCuretteKH EUDAMED
- Unit of Use DI
- 10859911004631 EUDAMED
- FDA Product Code
- JYG FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- ENT illuminating foreign body extraction set 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 Ear Curette 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 | 859911004LightedCuretteKH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bionix LLC
- EUDAMED SRN
- US-MF-000020408
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED cac016cc-f550-48f3-85c7-4c6aa98473dd 61 fields · synced May 30, 2026
- FDA UDI 0d105f03-c533-4fff-9859-380c437d700f 35 fields · synced May 30, 2026