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Carbon Dioxide Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref CO26011Y, CO26012Y, CO26013Y, CO26014Y, CO26015Y, CO26011N, CO26012N, CO26013N, CO26014N, CO26015N
Identity
- Trade Name
- Carbon Dioxide Reagent Kit EUDAMED
- Device Name
- Carbon Dioxide Reagent Kit EUDAMED
- Model / Reference
- CO26011Y, CO26012Y, CO26013Y, CO26014Y, CO26015Y, CO26011N, CO26012N, CO26013N, CO26014N, CO26015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CO26015U EUDAMED
- Basic UDI-DI
- B-CO26015U EUDAMED
- EMDN Code
- W0101070108 CARBON DIOXIDE (BICARBONATE) - ELECTRODES (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-CO26015U | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 49c3f6c4-a495-4c5a-ac45-b1ecaf86a774-1 61 fields · synced Jun 18, 2026
- EUDAMED 49c3f6c4-a495-4c5a-ac45-b1ecaf86a774-2 61 fields · synced Jun 18, 2026