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Portable Quantitative Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref RL-A2000
Identity
- Device Name
- Portable Quantitative Immunoassay Analyzer EUDAMED
- Model / Reference
- RL-A2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792050105 EUDAMED
- Basic UDI-DI
- 697179205AF3 EUDAMED
- Direct Marketing DI
- 06971792050105 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Portable Quantitative Immunoassay Analyzer by Hangzhou Realy Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697179205AF3 | Class A | Unknown |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 2f83b364-94db-467e-8089-49f5e97e4938 61 fields · synced Jun 18, 2026