Burnshield
by Burnshield (Pty) Ltd 13 variants
Ref L881085
Burnshield (L881085) is a Class IIb device made by Burnshield (Pty) Ltd, registered in EUDAMED on 25 Jun 2024 (Basic UDI-DI B-06007645004336), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06007645004336 06007645004336 | Date25 Jun 2024 | StatusActive |
Official records
- EUDAMED public site B-06007645004336
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Burnshield Burn Vest 24-36 Months
- Model / reference
- L881085
- Primary DI / UDI-DI
- 06007645004336
- Basic UDI-DI
- B-06007645004336
- EMDN code
- M0408 Dressings for burns only
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- ZA-MF-000018376
- Authorised representative
- Burnshield Europe B.V. NL-AR-000014621
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