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Fentex
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 300603FXModel Instrument zum Schaffen eines Sichtfelds.
Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Nasal speculum, reusable FDA UDI
- Device Name
- Nasal Speculum by Cottle black, with set screw 13 cm, blade length 50 mm FDA UDI
- Model / Reference
- 300603FX EUDAMEDFDA UDIInstrument zum Schaffen eines Sichtfelds. EUDAMED
- Description
- Nasal Speculum by Cottle black, with set screw 13 cm, blade length 50 mm FDA UDI
Identifiers
- Catalog Number
- 300603FX FDA UDI
- Primary DI / UDI-DI
- 04250407727161 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504077028K9 EUDAMED
- Direct Marketing DI
- 04250407727161 EUDAMED
- FDA Product Code
- EPY FDA UDI
- EMDN Code
- L149004 ENT SPECULUMS, REUSABLE EUDAMED
- GMDN Term
- Nasal speculum, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.1800 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: Nasal speculum, reusable
Fentex by FENTEX medical GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nasal speculum, reusable.
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- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Papavero Speculum, Titanium, 90x13mm Jaw — MIZUHO AMERICA, INC. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
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 60ba4db1-40ac-412f-a5dc-003c47d4b1ec 35 fields · synced Oct 7, 2026
- EUDAMED 412d949c-faa8-43fa-a16b-c144a69f349b 61 fields · synced Oct 7, 2026