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Carbon Dioxide (CO2) Assay Kit (Enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 94H50TSC
Identity
- Trade Name
- Carbon Dioxide (CO2) Assay Kit (Enzymatic Method) EUDAMED
- Device Name
- Carbon Dioxide (CO2) Assay Kit (Enzymatic Method) EUDAMED
- Model / Reference
- 94H50TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-94H50TSCVQ EUDAMED
- Basic UDI-DI
- B-94H50TSCVQ EUDAMED
- EMDN Code
- W0101060601 CARBON DIOXIDE - ELECTRODES (BG) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Carbon Dioxide (CO2) Assay Kit (Enzymatic Method) by Yhlo Biotech (nanjing) 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-94H50TSCVQ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 9b0751a9-0372-496c-be9e-2e4ef83d0f9a 61 fields · synced Oct 6, 2026