PRONOLIS HD One 2.2%
by Albomed GmbH EUDAMED
Active
Ref 03430Model Hyaluronate Intra-Articular Gel
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberD1478800026 | Date10 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- D1478800026 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0483
- Issued
- 10 Jun 2026
- Expires
- 17 Feb 2027
- Reason
- Other
Specification
- Model / Reference
- Hyaluronate Intra-Articular Gel, 03430
- Primary DI / UDI-DI
- 04250311909813
- Basic UDI-DI
- 42503119SOHY-ORTHO2G
- Direct Marketing DI
- 04250311909813
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000007875
Other devices from Albomed GmbH
Properties
Other properties (12)
- 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