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Calcium Assay Kit (Arsenazo III Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH080205Model R: 60 mL×2
Identity
- Device Name
- Calcium Assay Kit (Arsenazo III Method) EUDAMED
- Model / Reference
- R: 60 mL×2 EUDAMEDDTSH080205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460813 EUDAMED
- Basic UDI-DI
- B-06975225460813 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE 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
Category: Total aspartate aminotransferase (AST) IVD, reagent
Calcium Assay Kit (Arsenazo III Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Total aspartate aminotransferase (AST) IVD, reagent.
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- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · IVD General
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-06975225460813 | 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 (1)
- EUDAMED c33c9653-389f-446a-93e5-9fa459803b4f 61 fields · synced Jun 19, 2026