Farmakon a Y-3K 1, 25CA 3AS G 10LT
by KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.
Ref 459
Active
CE MDR
Valid until
10 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8699459938761PX 08699459934596 | Date12 Jun 2026 | StatusActive |
Certificates
- 2975-MED-2616201 Active
Quality management system EU MDR
- Certifier
- SZUTEST Konformitätsbewertungsstelle GmbH 2975
- Issued
- 11 Jun 2026
- Expires
- 10 Jun 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Farmakon Acidic Concentrate Hemodialysis Solution
- Model / Reference
- 459
- Primary DI / UDI-DI
- 08699459934596
- Basic UDI-DI
- 8699459938761PX
- EMDN Code
- F040101 Dialysis concentrates, acid solutions, non-sterile
- Device Class
- Class IIb
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000020885
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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