Identity
- Trade Name
- HOKAPI™ SAMPLE DILUENT 1 EUDAMED
- Device Name
- HOKAPI™ SAMPLE DILUENT 1 EUDAMED
- Model / Reference
- 0109092601 EUDAMED0109092001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716405516 EUDAMED06939716405509 EUDAMED
- Basic UDI-DI
- 69713904309098Z EUDAMED
- Direct Marketing DI
- 06939716405516 EUDAMED06939716405509 EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES 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
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™ Sample Diluent 1 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 | 69713904309098Z | 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 a318ad07-1287-4834-94f7-b3a3f638f9e5 61 fields · synced Jul 30, 2026
- EUDAMED 68a01b19-4b4a-4416-95c7-2b9b5d716158 61 fields · synced May 19, 2026