Prontosan® Wound Gel X
by B. Braun Medical AG 5 variants
Ref 400517
Active
CE MDR
Valid until
1 Oct 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number40392390000009232Q 04046964093425 | Date17 Sep 2026 | StatusActive |
Certificates
- 2247049CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 25 Sep 2024
- Expires
- 1 Oct 2028
- Reason
- Add device or group
- 2247049TD03 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 29 Nov 2023
- Expires
- 1 Oct 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Prontosan Wound Gel X
- Model / Reference
- 400517
- Primary DI / UDI-DI
- 04046964093425
- Basic UDI-DI
- 40392390000009232Q
- EMDN Code
- M04040502 Hydrogel dressings, combined with other substances
- Device Class
- Class III
- EU 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
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