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Calcium (Ca) Test Kit (Arsenazo Ⅲ)
EUDAMEDClass IVD General (EU MDR)
Ref R:20mL×2（702）Ref R:60mL×2（701）Ref R:70mL×2（700）Ref R:80mL×2（706）Ref R:40mL×4（792）Ref R:20mL×8（796）Ref R:40mL×4（705）
Identity
- Trade Name
- Calcium (Ca) Test Kit (Arsenazo Ⅲ) EUDAMEDCalcium (Ca) Test Kit (Arsenazo Ⅲ) EUDAMED
- Device Name
- Calcium (Ca) Test Kit (Arsenazo Ⅲ) EUDAMEDCalcium (Ca) Test Kit (Arsenazo Ⅲ) EUDAMED
- Model / Reference
- R:20mL×2（702） EUDAMEDR:60mL×2（701） EUDAMEDR:70mL×2（700） EUDAMEDR:80mL×2（706） EUDAMEDR:40mL×4（792） EUDAMEDR:20mL×8（796） EUDAMEDR:40mL×4（705） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674864936 EUDAMED06971674864912 EUDAMED06971674864905 EUDAMED06971674864967 EUDAMED06971674864981 EUDAMED06971674864998 EUDAMED06971674864950 EUDAMED
- Basic UDI-DI
- B-06971674864936 EUDAMEDB-06971674864912 EUDAMEDB-06971674864905 EUDAMEDB-06971674864967 EUDAMEDB-06971674864981 EUDAMEDB-06971674864998 EUDAMEDB-06971674864950 EUDAMED
- EMDN Code
- W01010303 CALCIUM 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
Calcium (Ca) Test Kit (Arsenazo Ⅲ) 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-06971674864936 | 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 (7)
- EUDAMED 78db0e43-7c77-4bfa-893c-58bdce953a55 61 fields · synced Aug 4, 2026
- EUDAMED c102ea79-664a-41a9-b3c6-a62d3b2ae186 61 fields · synced May 17, 2026
- EUDAMED a38ff3de-1d48-4c53-9441-ab6b48ca40bd 61 fields · synced May 17, 2026
- EUDAMED dafe57af-f12c-4647-abc4-4aefd21b7acc 61 fields · synced May 19, 2026
- EUDAMED 5909bba3-21d0-4d10-b7f6-420af7f10f09 61 fields · synced Jul 10, 2026
- EUDAMED 6cce21f0-178e-404c-8f4d-5f5ceca49e3b 61 fields · synced Aug 3, 2026
- EUDAMED 920eb861-fb48-4e6f-a5ec-b26512647228 61 fields · synced Aug 3, 2026