Sterile Hyaluronic Acid Intra-Articular Gel Implant
by Phibio GmbH
Ref VSPCModel 0.5ml - 1.0ml - 1.5ml - 2.0ml - 2.5ml - 3.0ml - 4.0ml - 5.0ml
Withdrawn
CE MDR, withdrawn
Ended
Withdrawn 23 Feb 2026
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426035399CRQZ 14260353990004 | Date7 Oct 2025 | StatusWithdrawn |
Certificates
- 1TD-MDR-0076/10/2025 Withdrawn
Technical documentation EU MDR
- Certifier
- Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi 2764
- Issued
- 2 Oct 2025
- Expires
- 1 Oct 2028
- Reason
- Not on market
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Device Name
- Sterile Hyaluronic Acid Intra-Articular Gel Implant
- Model / Reference
- 0.5ml - 1.0ml - 1.5ml - 2.0ml - 2.5ml - 3.0ml - 4.0ml - 5.0ml, VSPC
- Primary DI / UDI-DI
- 14260353990004
- Basic UDI-DI
- 426035399CRQZ
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
Manufacturer details
- EUDAMED SRN
- DE-MF-000045435
Other devices from Phibio GmbH
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