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Open Field Fluorescence Imaging Head
EUDAMEDClass IIa (EU MDR)
Ref 71-066-55 NIRModel OPTO-CHD3100E，71-066-55 NIRRef 71-066-50 NIRModel OPTO-CHD3100H, 71-066-50 NIR
Identity
- Trade Name
- Open Field Fluorescence Imaging Head EUDAMED
- Device Name
- Open Field Fluorescence Imaging Head EUDAMED
- Model / Reference
- OPTO-CHD3100E，71-066-55 NIR EUDAMED71-066-55 NIR EUDAMEDOPTO-CHD3100H, 71-066-50 NIR EUDAMED71-066-50 NIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031299481 EUDAMED06973031299498 EUDAMED
- Basic UDI-DI
- 697303129CHD0000198 EUDAMED697303129CHD000039C EUDAMED
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Open Field Fluorescence Imaging Head by Guangdong Optomedic Technologies, Inc. — Class IIa — 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 | 697303129CHD0000198 | Class IIa | 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 (2)
- EUDAMED c32eebc0-419e-4fa9-be57-784f6fc9b49f 61 fields · synced Sep 17, 2026
- EUDAMED 51aabbd3-fc7d-42de-8fa2-91ed23036a02 61 fields · synced May 18, 2026