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Image Processing Unit
EUDAMEDClass I (EU MDR)
Ref 71-066-05 NIRModel OPTO-CAM2100,71-066-05 NIR
Identity
- Trade Name
- Image Processing Unit EUDAMED
- Device Name
- Image Processing Unit EUDAMED
- Model / Reference
- OPTO-CAM2100,71-066-05 NIR EUDAMED71-066-05 NIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031299450 EUDAMED
- Basic UDI-DI
- 697303129CAM0000196 EUDAMED
- EMDN Code
- Z12020406,Z12020499 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Image Processing Unit by Guangdong Optomedic Technologies, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697303129CAM0000196 | Class I | Active |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED e970c722-c54c-4470-b3d6-daf8123993fd 61 fields · synced May 23, 2026