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Fentex
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 025103FXModel Instrument zum Abschaben beziehungsweise Abtragen.
Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Endaural surgical curette, reusable FDA UDI
- Device Name
- Ear Curette by Buck blunt 15 cm, size 3 FDA UDI
- Model / Reference
- 025103FX EUDAMEDFDA UDIInstrument zum Abschaben beziehungsweise Abtragen. EUDAMED
- Description
- Ear Curette by Buck blunt 15 cm, size 3 FDA UDI
Identifiers
- Catalog Number
- 025103FX FDA UDI
- Primary DI / UDI-DI
- 04250407702274 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504077001JM EUDAMED
- Direct Marketing DI
- 04250407702274 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- L149001 ENT CURETTES, REUSABLE EUDAMED
- GMDN Term
- Endaural surgical curette, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endaural surgical curette, reusable
Fentex by FENTEX medical GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Endaural surgical curette, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FENTEX medical GmbH
Sources (2)
- FDA UDI 63567372-e402-4881-8b06-5398e7815858 35 fields · synced Oct 8, 2026
- EUDAMED ce157060-e7c8-472a-b295-277a25ffdfef 61 fields · synced Oct 8, 2026