Identity
- Trade Name
- HOKAPI™ PTH EUDAMED
- Device Name
- HOKAPI™ PTH EUDAMED
- Model / Reference
- 011102101 EUDAMED011102601 EUDAMED011102001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716401792 EUDAMED06939716405325 EUDAMED06939716405318 EUDAMED
- Basic UDI-DI
- 693971641102L7 EUDAMED
- Direct Marketing DI
- 06939716401792 EUDAMED06939716405325 EUDAMED06939716405318 EUDAMED
- EMDN Code
- W0102060312 PARATHYROID HORMONE INTACT EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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™ Pth 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 | 693971641102L7 | 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 (3)
- EUDAMED b2e4bfe2-03bc-43e5-82e4-9c706d88c393 61 fields · synced Sep 18, 2026
- EUDAMED 8d613fc6-ec38-49cf-8f4b-0dc816d16afe 61 fields · synced May 17, 2026
- EUDAMED c7879896-a7b9-43b0-8d44-f965c91579a0 61 fields · synced May 18, 2026