Prontosan® Wound Gel X
by B. Braun Medical AG Switzerland EUDAMED
Ref 400508 EMDN M04040502
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number40392390000009232Q | Date17 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2247049CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 25 Sep 2024
- Expires
- 1 Oct 2028
- Reason
- Add device or group
- 2247049TD03 Amended
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 29 Nov 2023
- Expires
- 1 Oct 2028
- Reason
- Other
Specification
- Device Name
- Prontosan Wound Gel X
- Model / Reference
- 400508
- Primary DI / UDI-DI
- 04046963840174
- Basic UDI-DI
- 40392390000009232Q
- EMDN Code
- M04040502 Hydrogel dressings, combined with other substances
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000017781
- Authorised representative
- B. Braun Melsungen AG DE-AR-000000202
Other devices from B. Braun Medical AG
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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
Sources (1)
- EUDAMED 04046963840174|40392390000009232Q