← Back to catalogue
Bicarbonate (CO2)
EUDAMEDClass IVD General (EU MDR)
Ref B21046Model Bicarbonate 25 mLRef B27045Model BICARBONATE (CO2) Kit 100mLRef B33045Ref B28045Model BICARBONATE (CO2) Kit Ref B35045
Identity
- Trade Name
- Bicarbonate (CO2) EUDAMEDBICARBONATE (CO2) Kit EUDAMED
- Device Name
- Bicarbonate (CO2) EUDAMEDBICARBONATE (CO2) Kit EUDAMED
- Model / Reference
- Bicarbonate 25 mL EUDAMEDB21046 EUDAMEDBICARBONATE (CO2) Kit 100mL EUDAMEDB27045 EUDAMEDB33045 EUDAMEDBICARBONATE (CO2) Kit EUDAMEDB28045 EUDAMEDB35045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555610188 EUDAMED08683555612465 EUDAMED08683555615596 EUDAMED08683555618566 EUDAMED08683555619464 EUDAMED
- Basic UDI-DI
- B-08683555610188 EUDAMEDB-08683555612465 EUDAMEDB-08683555615596 EUDAMEDB-08683555618566 EUDAMEDB-08683555619464 EUDAMED
- EMDN Code
- W01010302 BICARBONATE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
Bicarbonate (CO2) by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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-08683555610188 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (5)
- EUDAMED 6bda83a9-fbcd-44b8-8a0a-4820a3d592e3 61 fields · synced Oct 6, 2026
- EUDAMED ec1c5a62-72c9-449f-ba40-674dfba03e29 61 fields · synced May 16, 2026
- EUDAMED 210f1f0b-3bd6-4f9d-a2fd-b510ad5a19c7 61 fields · synced May 18, 2026
- EUDAMED 034e7787-1a27-47a8-8792-92c95b9eb08b 61 fields · synced May 19, 2026
- EUDAMED 5aafd0f6-ead9-463f-8da0-c88dcdd6ec5a 61 fields · synced May 19, 2026