Identity
- Trade Name
- HOKAPI™ FOLATE EUDAMED
- Device Name
- HOKAPI™ FOLATE EUDAMED
- Model / Reference
- 010905001 EUDAMED010905601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716405462 EUDAMED06939716405479 EUDAMED
- Basic UDI-DI
- 693971640905ME EUDAMED
- Direct Marketing DI
- 06939716405462 EUDAMED06939716405479 EUDAMED
- EMDN Code
- W0102070103 FOLATE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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™ Folate by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class B — 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 | 693971640905ME | Class B | 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 15a6633f-1444-497f-9b47-9fe80caf4799 61 fields · synced Jul 27, 2026
- EUDAMED fe7c0b0e-6707-4a58-b057-1f90c2e3a055 61 fields · synced May 17, 2026