Identity
- Trade Name
- HOKAPI™ CUVETTE EUDAMED
- Device Name
- HOKAPI™ CUVETTE EUDAMED
- Model / Reference
- AE20-FL00-0007 EUDAMEDAE20-FL00-0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404366 EUDAMED06939716404359 EUDAMED
- Basic UDI-DI
- 697139043AE1800126N EUDAMED
- Direct Marketing DI
- 06939716404366 EUDAMED06939716404359 EUDAMED
- EMDN Code
- W0503010203 SAMPLES ANALYSES, PLASTIC CUVETTES 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
No
EUDAMED
New Device
No
EUDAMED
Hokapi™ Cuvette 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 | 697139043AE1800126N | Class A | Active |
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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 (2)
- EUDAMED 43a27ca0-7956-4878-92bf-c9ecc9a96702 61 fields · synced Jul 15, 2026
- EUDAMED ce9ba1fe-19c5-4cc8-a1a1-c8e0eaa19d86 61 fields · synced May 18, 2026