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 LED 2.2 80W LED, low operating noise level, dialog function, LED, buttons, compatible with core nova, universal light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 300x160x424mm FDA UDI
- Model / Reference
- 10000201092 EUDAMED5164001 EUDAMEDFDA UDI
- Description
- LIGHT SOURCE LED 2.2 80W LED, low operating noise level, dialog function, LED, buttons, compatible with core nova, universal light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 300x160x424mm FDA UDI
Identifiers
- Catalog Number
- 5164001 FDA UDI
- Primary DI / UDI-DI
- 04055207055212 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017664PT EUDAMED
- Direct Marketing DI
- 04055207055212 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
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Also classified as Endoscopic light source unit, line-powered.
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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 |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 2d32ae81-5be5-4472-a1dc-d8a203e8980f 61 fields · synced Jun 17, 2026
- FDA UDI 8be2f138-8c85-42b4-82b7-b774279c3aaf 35 fields · synced May 29, 2026