Hydrogel eye pad
by Guangdong TiDaKang Medical Technology Co., Ltd. EUDAMED
Active
Ref Binocular (21.6cm×8.3cm) / Monocular(15.5cm×6cm) / Monocular(9cm×7cm)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-610HEK4 | Date7 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Model / Reference
- Binocular (21.6cm×8.3cm) / Monocular(15.5cm×6cm) / Monocular(9cm×7cm)
- Primary DI / UDI-DI
- D-610HEK4
- Basic UDI-DI
- B-610HEK4
- EMDN Code
- M040399 Ophthalmic dressings - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000025927
- Authorised representative
- MedPath GmbH DE-AR-000000087
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Properties
Other properties (10)
- Implantable: No
- 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