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Fluorescence Image Analysis Workstation
EUDAMEDClass I (EU MDR)
Ref OPTO-FM1000Model OPTO-FM1000, 71-920-00 NIRRef 71-920-00 NIR
Identity
- Trade Name
- Fluorescence Image Analysis Workstation EUDAMED
- Device Name
- Fluorescence Image Analysis Workstation EUDAMED
- Model / Reference
- OPTO-FM1000, 71-920-00 NIR EUDAMEDOPTO-FM1000 EUDAMED71-920-00 NIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031299276 EUDAMED06973031299269 EUDAMED
- Basic UDI-DI
- 697303129FM01014Y EUDAMED
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMEDZ12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fluorescence Image Analysis Workstation 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 | 697303129FM01014Y | 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 (2)
- EUDAMED 76685dc4-8941-4169-9e3a-87a0e6072b93 61 fields · synced Jul 24, 2026
- EUDAMED a2c986f2-8a96-45ac-be89-92726ddc5f6f 61 fields · synced May 17, 2026