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Fentex
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 530150FXModel Instrumente zur Erweiterung und Darstellung verschiedener Larynx-Anatomien zur Unterstützung chirurgischer Eingriffe.
Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Rigid optical laryngopharyngoscope FDA UDI
- Device Name
- Operating Laryngoscope with Endoscope Support FDA UDI
- Model / Reference
- 530150FX EUDAMEDFDA UDIInstrumente zur Erweiterung und Darstellung verschiedener Larynx-Anatomien zur Unterstützung chirurgischer Eingriffe. EUDAMED
- Description
- Operating Laryngoscope with Endoscope Support FDA UDI
Identifiers
- Catalog Number
- 530150FX FDA UDI
- Primary DI / UDI-DI
- 04250407781286 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504077302K6 EUDAMED
- Direct Marketing DI
- 04250407781286 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Rigid optical laryngopharyngoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 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: Rigid optical laryngopharyngoscope
Fentex by FENTEX medical GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 0af79424-cdab-4c86-95e5-532f972c80ce 35 fields · synced Oct 8, 2026
- EUDAMED 285edab8-8c59-4f1e-b80b-894895109d40 61 fields · synced Oct 8, 2026