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Getein1200 Immunofluorescence Quantitative Analyzer
EUDAMEDClass A (EU MDR)
Ref Getein1200
Identity
- Trade Name
- Getein1200 Immunofluorescence Quantitative Analyzer EUDAMED
- Device Name
- Getein1200 Immunofluorescence Quantitative Analyzer EUDAMED
- Model / Reference
- Getein1200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414713350 EUDAMED
- Basic UDI-DI
- 695441471335HM EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Getein1200 Immunofluorescence Quantitative Analyzer by Getein Biotech, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 695441471335HM | Class A | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 18f16361-b1a3-424a-b9de-9cb8b735f9dc 61 fields · synced Jun 20, 2026