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Hokapi™ Beta2-Mg
EUDAMEDClass B (EU MDR)
Ref 010606601Ref 010606101Ref 010606001
Identity
- Trade Name
- HOKAPI™ BETA2-MG EUDAMED
- Device Name
- HOKAPI™ BETA2-MG EUDAMED
- Model / Reference
- 010606601 EUDAMED010606101 EUDAMED010606001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716405127 EUDAMED06971390439890 EUDAMED06939716405110 EUDAMED
- Basic UDI-DI
- 69713904306068C EUDAMED
- Direct Marketing DI
- 06939716405127 EUDAMED06971390439890 EUDAMED06939716405110 EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN 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
Category: Beta-2-microglobulin IVD, reagent
Hokapi™ Beta2-Mg by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Beta-2-microglobulin IVD, reagent.
- Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method) — WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General
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 | 69713904306068C | 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 7f54de96-0538-453a-8871-8f0e19c07b15 61 fields · synced Jul 25, 2026
- EUDAMED 7e84154e-5c4a-40f8-beaf-681ac4f3100d 61 fields · synced May 11, 2026
- EUDAMED 57fe1c91-8ddf-4e76-ab54-28e1e60ef194 61 fields · synced May 18, 2026