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Ilo
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 854-0031Model 3Chip (MOS) UHD camera system
Identity
- Trade Name
- M-CAM 4K EUDAMEDILO FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- Endoscopic camera EUDAMED3MOS UHD camera FDA UDI
- Model / Reference
- 3Chip (MOS) UHD camera system EUDAMED854-0031 EUDAMEDTRIstar 4K USB FDA UDI
- Description
- 3MOS UHD camera FDA UDI
Identifiers
- Catalog Number
- 854-0030 FDA UDI
- Primary DI / UDI-DI
- 04250369706655 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503697854P5 EUDAMED
- Direct Marketing DI
- 04250369706655 EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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: Endoscope video cameraEndoscopic video image processing unit
Ilo by ILO electronic GmbH — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ILO electronic GmbH
Sources (2)
- FDA UDI 50ee68bb-f235-411b-8f4d-c7df09bd5e6e 35 fields · synced Jul 9, 2026
- EUDAMED 3248bcac-0b61-4f18-b420-62dbeee9f4f4 61 fields · synced Jul 9, 2026