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Urea Assay Kit (UV-glutamate Dehydrogenase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030308Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH030302Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH030307Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH030306Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH030305Model R1: 20 mL×1; R2: 5 mL×1
Identity
- Device Name
- Urea Assay Kit (UV-glutamate Dehydrogenase Method) EUDAMED
- Model / Reference
- R1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH030308 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH030302 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH030307 EUDAMEDR1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH030306 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH030305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461544 EUDAMED06975225461568 EUDAMED06975225461537 EUDAMED06975225461520 EUDAMED06975225461513 EUDAMED
- Basic UDI-DI
- B-06975225461544 EUDAMEDB-06975225461568 EUDAMEDB-06975225461537 EUDAMEDB-06975225461520 EUDAMEDB-06975225461513 EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN 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
Yes
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
Urea Assay Kit (UV-glutamate Dehydrogenase 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-06975225461544 | 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 (5)
- EUDAMED 2d36e984-d877-4680-bb9b-1c4c5aae195b 61 fields · synced Aug 4, 2026
- EUDAMED f50feb8f-f1b1-42f6-b42b-bc996eb0a861 61 fields · synced May 17, 2026
- EUDAMED 07ebb40a-f132-4b50-8c45-20a5d0562110 61 fields · synced May 17, 2026
- EUDAMED 841b6550-f1fc-4e18-8de5-fa60435bc709 61 fields · synced May 18, 2026
- EUDAMED fa077c28-77ed-4a24-bc5a-20d7d2308bbb 61 fields · synced May 19, 2026