Kanstat
by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. 6 variants
Ref KL08Model Kanstat Fibril, Kanstat Fabric, Kanstat ORJ, Kanstat Felt
Active
CE MDR CE MDD
Valid until
26 Oct 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00115-B | Date12 Dec 2025 | StatusActive |
| European Union | CE/MDD | NumberB-08698147970601 08698147970601 | Date19 Aug 2024 | StatusActive |
Certificates
- MDR 00115-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 27 Oct 2025
- Expires
- 26 Oct 2030
- MDR 00115-B Active
Technical documentation EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 12 Dec 2025
- Expires
- 26 Oct 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Kanstat ORJ
- Model / Reference
- KL08, Kanstat Fibril, Kanstat Fabric, Kanstat ORJ, Kanstat Felt
- Primary DI / UDI-DI
- 08698147970601
- Basic UDI-DI
- B-08698147970601, 8698147H100K0P7
- EMDN Code
- M040501 Polysaccharide haemostatic dressings
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000016026
Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.
Properties
Other properties (11)
- 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