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Ilo
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 825-0303Model LED Cold light source
Identity
- Trade Name
- M-LED 3000plus EUDAMEDILO FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- Endoscopic light source EUDAMEDLED light source 5600K CRI90 FDA UDI
- Model / Reference
- LED Cold light source EUDAMED825-0303 EUDAMEDM-LED 3000plus FDA UDI
- Description
- LED light source 5600K CRI90 FDA UDI
Identifiers
- Catalog Number
- 825-0302 FDA UDI
- Primary DI / UDI-DI
- 04250369706785 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503697825NW EUDAMED
- Direct Marketing DI
- 04250369706785 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic light source unit, line-powered
Ilo by ILO electronic GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- ILO electronic GmbH
Sources (2)
- FDA UDI e244c3e4-ad70-4bc7-9b70-0fa3e5ea6ba5 35 fields · synced Jun 18, 2026
- EUDAMED b195724c-d158-4dab-93ba-66ac8c45c60c 61 fields · synced Jun 18, 2026