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Albumin Assay Kit (Bromocresol Green Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH021201Model R: 60 mL×6Ref DTSH021202Model R: 40 mL×6
Identity
- Device Name
- Albumin Assay Kit (Bromocresol Green Method) EUDAMED
- Model / Reference
- R: 60 mL×6 EUDAMEDDTSH021201 EUDAMEDR: 40 mL×6 EUDAMEDDTSH021202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461117 EUDAMED06975225461100 EUDAMED
- Basic UDI-DI
- B-06975225461117 EUDAMEDB-06975225461100 EUDAMED
- EMDN Code
- W01010201 ALBUMIN (CC) 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
Albumin Assay Kit (Bromocresol Green 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-06975225461117 | 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 708fa742-f069-4a32-8bb2-819129317d8e 61 fields · synced Jul 9, 2026
- EUDAMED 08707a34-1991-4882-85f7-65726b2bdf4f 61 fields · synced May 18, 2026