Farmakon a 1K 138NA 1.75CA 3AS G 5LT Acidic Concentrate Hemodialysis Solution
by KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.
Ref 537
Active
CE MDR CE MDD
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 | NumberB-8699459935371NR D-8699459935371NR | Date13 May 2023 | StatusActive |
| European Union | CE/MDD | NumberB-8699459935371NR D-8699459935371NR | Date13 May 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- Withdrawn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, CE/MDD Active
Specification
- Model / Reference
- 537
- Primary DI / UDI-DI
- D-8699459935371NR
- Basic UDI-DI
- B-8699459935371NR
- 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 (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No