← Back to catalogue
05.0088l.ht
EUDAMEDFDA UDIClass I (EU MDR)
Ref 05.0088l.htModel Fiberoptic Light Guides
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Light Guide 3.5 x 2300 mm, HT version FDA UDI
- Model / Reference
- Fiberoptic Light Guides EUDAMED05.0088l.ht EUDAMEDFDA UDI
- Description
- Light Guide 3.5 x 2300 mm, HT version FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480106976 EUDAMEDFDA UDI04250480101902 EUDAMED
- Basic UDI-DI
- 42504801FOLIGHTGUIDESHV EUDAMED
- Direct Marketing DI
- 04250480106976 EUDAMED04250480101902 EUDAMED
- FDA Product Code
- EQH FDA UDI
- EMDN Code
- Z12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4350 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 2300 Millimeter FDA UDI
05.0088l.ht by SCHÖLLY FIBEROPTIC GmbH — 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 | 42504801FOLIGHTGUIDESHV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (3)
- EUDAMED 76800162-2542-436c-ad81-f33512315249 61 fields · synced Jul 17, 2026
- EUDAMED 81a936b9-6949-4fbb-bacc-82998c851657 61 fields · synced May 19, 2026
- FDA UDI e6ad0642-2f97-4a30-bac3-6895901cbbe3 36 fields · synced May 30, 2026