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Calcium Assay Kit (Arsenazo III Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH080202Model R: 40 mL×6Ref DTSH080207Model R: 90 mL×4Ref DTSH080206Model R: 60 mL×6
Identity
- Device Name
- Calcium Assay Kit (Arsenazo III Method) EUDAMED
- Model / Reference
- R: 40 mL×6 EUDAMEDDTSH080202 EUDAMEDR: 90 mL×4 EUDAMEDDTSH080207 EUDAMEDR: 60 mL×6 EUDAMEDDTSH080206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460820 EUDAMED06975225460844 EUDAMED06975225460837 EUDAMED
- Basic UDI-DI
- B-06975225460820 EUDAMEDB-06975225460844 EUDAMEDB-06975225460837 EUDAMED
- EMDN Code
- W01010303 CALCIUM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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 Assay Kit (Arsenazo III Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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-06975225460820 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED a89534c7-4b94-44cb-a3b8-50fcfda69584 61 fields · synced Aug 2, 2026
- EUDAMED 466dd8a6-3680-435c-ad20-ecc400c93ec0 61 fields · synced May 17, 2026
- EUDAMED 92d3d5cc-8f5c-4ba3-aaf3-dcaa774676d9 61 fields · synced May 17, 2026