Orthix Plus Inj.
by YooYoung Pharmaceutical Co., Ltd.
Ref ENPR236 / TEPR236Model Orthix Plus Inj.
Active
CE MDD
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/MDD | NumberB-08806103500070 08806103500070 | Date31 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- Withdrawn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/MDD Active
Specification
- Device Name
- Orthix Plus Inj. Sterile Absorbable Viscoelastic Solution (Sodium Hyaluronate Solution) for Arthritis
- Model / Reference
- Orthix Plus Inj., ENPR236 / TEPR236
- Primary DI / UDI-DI
- 08806103500070
- Basic UDI-DI
- B-08806103500070
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- KR-MF-000017424
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from YooYoung Pharmaceutical Co., Ltd.
Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No