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05-0762nir
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05-0762nirModel NIR Light Sources
Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- NIR FI+ Light Source FDA UDI
- Model / Reference
- NIR Light Sources EUDAMED05-0762nir EUDAMEDFDA UDI
- Description
- NIR FI+ Light Source FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480104262 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504801NIRLIGHTSOURCESQK EUDAMED
- Direct Marketing DI
- 04250480104262 EUDAMED
- FDA Product Code
- GCJ FDA UDIFET FDA UDIFCW FDA UDI
- EMDN Code
- Z12029007 INFRA–RED SURGICAL ILLUMINATORS EUDAMED
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
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
05-0762nir by SCHÖLLY FIBEROPTIC GmbH — Class IIa — 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 | 42504801NIRLIGHTSOURCESQK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (2)
- EUDAMED 197ed88e-5590-4e8b-b2c6-cc10c1ed31f7 61 fields · synced Jul 12, 2026
- FDA UDI 711a256d-5671-4faa-8632-eda68a04634d 35 fields · synced May 30, 2026