Farmakon B35 10LT
by KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti. Türkiye EUDAMED
Ref 997
EMDN F040202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8699459939980QL | Date12 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2975-MED-2616201 Issued
Quality management system EU MDR
- Notified body
- Notified body 2975
- Issued
- 11 Jun 2026
- Expires
- 10 Jun 2031
Specification
- Device Name
- Farmakon Basic Concentrate Hemodialysis Solution
- Model / Reference
- 997
- Primary DI / UDI-DI
- 08699459939973
- Basic UDI-DI
- 8699459939980QL
- EMDN Code
- F040202 Dialysis concentrates, basic solutions, liquid
- Device Class
- Class IIb
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000020885
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 854a29fd-0138-477e-8080-279c126f857d