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Magnesium Assay Kit (Xylidyl Blue Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH080306Model R: 20 mL×4Ref DTSH080301Model R: 60 mL×6
Identity
- Device Name
- Magnesium Assay Kit (Xylidyl Blue Method) EUDAMED
- Model / Reference
- R: 20 mL×4 EUDAMEDDTSH080306 EUDAMEDR: 60 mL×6 EUDAMEDDTSH080301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461148 EUDAMED06975225461162 EUDAMED
- Basic UDI-DI
- B-06975225461148 EUDAMEDB-06975225461162 EUDAMED
- EMDN Code
- W01010306 MAGNESIUM 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
Magnesium Assay Kit (Xylidyl Blue 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-06975225461148 | 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 (2)
- EUDAMED 3a07c59a-b170-4070-bfc0-35fffbaec7b5 61 fields · synced Jul 18, 2026
- EUDAMED 14b0a7e1-eb71-4c0f-8664-19baf0765633 61 fields · synced May 18, 2026