Pe-Ha-Luron F 1.4%
Ref 04421Model Sodium Hyaluronate Intra-Ocular Gel
Active
CE MDR
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 | Number42503119SOHY-F-OPHTHA7K 04250311908847 | Date23 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Sodium Hyaluronate Intra-Ocular Gel, 04421
- Primary DI / UDI-DI
- 04250311908847
- Basic UDI-DI
- 42503119SOHY-F-OPHTHA7K
- Direct Marketing DI
- 04250311908847
- EMDN Code
- Q02030301 Ophthalmology, hyaluronic acid and derivatives
- Device Class
- Class IIb
- EU 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