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R1:40mL×2 R2:13mL×2(713)
EUDAMEDClass IVD General (EU MDR)
Ref R1:40mL×2 R2:13mL×2(713)
Identity
- Trade Name
- R1:40mL×2 R2:13mL×2(713) EUDAMED
- Device Name
- Homocysteine (HCY) Test Kit (Enzymatic) EUDAMED
- Model / Reference
- R1:40mL×2 R2:13mL×2(713) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674868712 EUDAMED
- Basic UDI-DI
- B-06971674868712 EUDAMED
- EMDN Code
- W01021307 HOMOCYSTEINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
R1:40mL×2 R2:13mL×2(713) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674868712 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED dc2be05e-d371-4761-aede-c4850e4a6580 61 fields · synced Oct 6, 2026