Ap
by Jiangsu Jiele Medical Dressing Co., Ltd China EUDAMED
Ref PRA10X10Model 10x10
EMDN M040499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-16975069551804 | Date26 Aug 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Model / Reference
- PRA10X10, 10x10
- Primary DI / UDI-DI
- 16975069551804, 06975069551807
- Basic UDI-DI
- B-16975069551804, B-06975069551807
- EMDN Code
- M040499 Dressings for wounds, sores and ulcerations - other
- Device Class
- Class IIb
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000008773
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED aa437739-945e-4066-ad86-3e710334a297
- EUDAMED 06975069551807|B-06975069551807