Identity
- Trade Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Dry-type Fluorescent Immunoassay Analyzer (Single channel) EUDAMED
- Model / Reference
- AFR-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983155052 EUDAMED
- Basic UDI-DI
- 6970277510004YZ7 EUDAMED
- Direct Marketing DI
- 06936983155052 EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland 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
Fluorescence Immunoassay Analyzer by Hangzhou Alltest Biotech.Co., Ltd. — 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 | 6970277510004YZ7 | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED fd097d20-2529-4b7e-b073-eda5bcb40296 61 fields · synced Jun 11, 2026