Identity
- Trade Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- AFE-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978151200140 EUDAMED
- Basic UDI-DI
- 697815120FIAAFE-101JQ EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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 Aichek Medical Technology 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 | 697815120FIAAFE-101JQ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 72be7e06-2491-4b75-bab5-5cf1904bcfd4 61 fields · synced Aug 1, 2026