HP cell Vitaran J
Ref Polynucleotides intra-articular gelModel HP cell Vitaran J
Active
CE MDR
Valid until
10 Jul 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2026-MDR/QS-050 | Date10 Jul 2026 | StatusActive |
Certificates
- 2026-MDR/QS-050 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 10 Jul 2026
- Expires
- 10 Jul 2031
- 2026-MDR/TD-050 Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 10 Jul 2026
- Expires
- 10 Jul 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Polynucleotides intra-articular gel
- Model / Reference
- HP cell Vitaran J, Polynucleotides intra-articular gel
- Primary DI / UDI-DI
- 08809360971522
- Basic UDI-DI
- 8809360970002AN
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000027339
- Authorised representative
- KTR Europe GmbH DE-AR-000005685
Other devices from BR Pharm Co., Ltd.
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No