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Fentex
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 530304FXModel 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 by Holinger with light carrier 17 cm FDA UDI
- Model / Reference
- 530304FX EUDAMEDFDA UDIInstrumente zur Erweiterung und Darstellung verschiedener Larynx-Anatomien zur Unterstützung chirurgischer Eingriffe. EUDAMED
- Description
- Operating Laryngoscope by Holinger with light carrier 17 cm FDA UDI
Identifiers
- Catalog Number
- 530304FX FDA UDI
- Primary DI / UDI-DI
- 04250407741211 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504077302K6 EUDAMED
- Direct Marketing DI
- 04250407741211 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 50a4003c-08a3-4915-9cd4-03b78cf5a8b1 35 fields · synced Oct 8, 2026
- EUDAMED 7ab3138c-cacd-4dc9-819f-1c87ae4cf439 61 fields · synced Oct 8, 2026