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Light sources with LED
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5160001Model 10000201092
Identity
- Trade Name
- ENDOLIGHT FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- Light sources with LED EUDAMEDLIGHT SOURCE LED 1.1 76W LED, low operating noise level, LED, buttons, WOLF light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 300x120x421mm FDA UDI
- Model / Reference
- 10000201092 EUDAMED5160001 EUDAMEDFDA UDI
- Description
- LIGHT SOURCE LED 1.1 76W LED, low operating noise level, LED, buttons, WOLF light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 300x120x421mm FDA UDI
Identifiers
- Catalog Number
- 5160001 FDA UDI
- Primary DI / UDI-DI
- 04055207012918 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017664PT EUDAMED
- Direct Marketing DI
- 04055207012918 EUDAMED
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class I 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
No
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
Light sources with LED by Richard Wolf 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 | 405520727052019-0017664PT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED b291b5c3-993e-4f5c-b007-d3d1e9fa46de 61 fields · synced Jul 9, 2026
- FDA UDI b82cb873-8850-4cb5-97da-9efeeddd2e33 35 fields · synced May 30, 2026