Light sources with LED
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- ENDOLIGHT FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- Light sources with LED EUDAMEDLIGHT SOURCE FLEX LED 42W LED, low operating noise level, LED, buttons, WOLF light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 150x55x220mm FDA UDI
- Model / Reference
- 10000201092 EUDAMED5166001 EUDAMEDFDA UDI
- Description
- LIGHT SOURCE FLEX LED 42W LED, low operating noise level, LED, buttons, WOLF light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 150x55x220mm FDA UDI
Identifiers
- Catalog Number
- 5166001 FDA UDI
- Primary DI / UDI-DI
- 04055207055229 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017664PT EUDAMED
- Direct Marketing DI
- 04055207055229 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic light source unit, line-powered
Light sources with LED by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light source unit, line-powered.
- Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
- SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
- SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
- LED 610 Light source — Erbe Vision GmbH · Class I
- SPOTLIGHT — Depuy Spine, Inc. · Class II
- SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED eae1cc37-93db-4650-b5e3-fe71c4667ba0 61 fields · synced Jun 18, 2026
- FDA UDI 29e3bd01-4a02-455f-8e17-e5b2f716f694 36 fields · synced May 30, 2026