Identity
- Trade Name
- HOKAPI™ AE-200 EUDAMED
- Device Name
- HOKAPI™ AE-200 EUDAMED
- Model / Reference
- AE-200 EUDAMEDAE20-MA00-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716402430 EUDAMED
- Basic UDI-DI
- 69397164AE200LV EUDAMED
- Direct Marketing DI
- 06939716402430 EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Hokapi™ Ae-200 by Suzhou Hokapi Biomedical Engineering 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 | 69397164AE200LV | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suzhou Hokapi Biomedical Engineering Co., Ltd..
- EUDAMED SRN
- CN-MF-000013723
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 003e283f-ff61-47e6-9366-4b80ff2ffd28 61 fields · synced Jun 18, 2026