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Carbon Dioxide (CO2) (Colorimetric PEPC)
EUDAMEDClass IVD General (EU MDR)
Ref D-616 002Ref D-616 003
Identity
- Trade Name
- Carbon Dioxide (CO2) (Colorimetric PEPC) EUDAMED
- Device Name
- Carbon Dioxide (CO2) (Colorimetric PEPC) EUDAMED
- Model / Reference
- D-616 002 EUDAMEDD-616 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182712396 EUDAMED62230182712228 EUDAMED
- Basic UDI-DI
- B-62230182712396 EUDAMEDB-62230182712228 EUDAMED
- EMDN Code
- W01010302 BICARBONATE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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) (Colorimetric PEPC) by Kalians Corporation — 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-62230182712396 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 75723162-12a3-4826-bbad-7797636dff34 61 fields · synced Aug 1, 2026
- EUDAMED d6e5bdcb-aa16-469d-92b4-803a0b6d53b4 61 fields · synced May 17, 2026