Farmakon a 2K 1, 75CA G AS5 8LT Acidic Concentrate Hemodialysis Solution
by KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.
Ref 638
Active
CE MDR CE MDD
Valid until
10 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2975-MED-2616201 | Date11 Jun 2026 | StatusActive |
| European Union | CE/MDD | NumberB-8699459936385PB | Date12 May 2023 | 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- Withdrawn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, CE/MDD Active
Specification
- Trade Name
- Farmakon a 2K 1,75CA G AS5 8LT Acidic Concentrate Hemodialysis SolutionFarmakon a 2K 1,75CA G AS5 8LT
- Device Name
- Farmakon Acidic Concentrate Hemodialysis Solution
- Model / Reference
- 638
- Primary DI / UDI-DI
- D-8699459936385PB, 08699459936385
- Basic UDI-DI
- B-8699459936385PB, 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