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Carbon Dioxide Assay Kit (Enzyme Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH080105Model R: 60 mL×2Ref DTSH080103Model R: 90 mL×4Ref DTSH080106Model R: 20 mL×4Ref DTSH080108Model R: 60 mL×6
Identity
- Device Name
- Carbon Dioxide Assay Kit (Enzyme Method) EUDAMED
- Model / Reference
- R: 60 mL×2 EUDAMEDDTSH080105 EUDAMEDR: 90 mL×4 EUDAMEDDTSH080103 EUDAMEDR: 20 mL×4 EUDAMEDDTSH080106 EUDAMEDR: 60 mL×6 EUDAMEDDTSH080108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462558 EUDAMED06975225462596 EUDAMED06975225462565 EUDAMED06975225462589 EUDAMED
- Basic UDI-DI
- B-06975225462558 EUDAMEDB-06975225462596 EUDAMEDB-06975225462565 EUDAMEDB-06975225462589 EUDAMED
- EMDN Code
- W01010302 BICARBONATE 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
Carbon Dioxide Assay Kit (Enzyme 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-06975225462558 | 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 (4)
- EUDAMED 464b0ca6-069e-4f83-bf67-127ba9f135d4 61 fields · synced Jul 25, 2026
- EUDAMED b3b22b8e-7264-435d-a50d-a05fb27b044a 61 fields · synced May 18, 2026
- EUDAMED 1aa13009-c03d-4492-96e0-a53b8e08b5b6 61 fields · synced May 18, 2026
- EUDAMED 0dd15138-e326-4bee-8b40-adb712731c64 61 fields · synced May 19, 2026