Identity
- Trade Name
- Light source , for flexible endoscopes EndoLED EUDAMEDOlympus FDA UDI
- Generic Name
- Endoscopic light source unit, battery-powered FDA UDI
- Device Name
- Light source (Portable) - EndoLED EUDAMEDLight source "EndoLED", for flexible endoscopes FDA UDI
- Model / Reference
- WA91502A EUDAMEDFDA UDI
- Description
- Light source "EndoLED", for flexible endoscopes FDA UDI
Identifiers
- Catalog Number
- WA91502A FDA UDI
- Primary DI / UDI-DI
- 04042761073592 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761110214L EUDAMED
- Direct Marketing DI
- 04042761073592 EUDAMED
- 510(k) Number
- K133311 FDA UDI
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, battery-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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Endoscopic light source unit, battery-powered
Olympus by Olympus Winter & Ibe GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Endoscopic light source unit, battery-powered.
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Cleared under the same submission
K133311 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (2)
- FDA UDI 66e2f267-153c-4611-b5e5-5aeb8d5cf21c 36 fields · synced Jul 11, 2026
- EUDAMED 56c32483-d8a8-4dff-ae48-5997a3f53460 61 fields · synced Jul 11, 2026