Bicarbonate Cartridge
Ref BIO CARB G 650 gm, BIO CARB G 720 gm, BIO CARB G 740 gm and BIO CARB G 750 gmModel Biocarb G 650 gm, Biocarb G 720 gm, Biocarb G 740 gm and Biocarb G 750 gm
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6221166BIOCARBK2 06221166006062 | Date19 Jan 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sodium Bicarbonate Cartridge/Bicarbonate Cartridge
- Model / Reference
- Biocarb G 650 gm, Biocarb G 720 gm, Biocarb G 740 gm and Biocarb G 750 gm, BIO CARB G 650 gm, BIO CARB G 720 gm, BIO CARB G 740 gm and BIO CARB G 750 gm
- Primary DI / UDI-DI
- 06221166006062
- Basic UDI-DI
- 6221166BIOCARBK2
- EMDN Code
- F040201 Dialysis concentrates, basic solutions, powder
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- EG-MF-000025747
- Authorised representative
- Allmed Medical GmbH DE-AR-000007830
Other devices from Allmed Middle East
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No