Identity
- Trade Name
- Burnshield EUDAMEDFDA UDI
- Generic Name
- Synthetic polymer burn dressing, gel-coated FDA UDI
- Device Name
- Burnshield Digit Dressing 25mmx500mm (1"x20") EUDAMEDBURNSHIELD DRESSING 25MMX0.50M (1X20") DIGIT FDA UDI
- Model / Reference
- L901130 EUDAMED901130 FDA UDI
- Description
- BURNSHIELD DRESSING 25MMX0.50M (1X20") DIGIT FDA UDI
Identifiers
- Catalog Number
- 901130 FDA UDI
- Primary DI / UDI-DI
- 06007645001434 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06007645001434 EUDAMED
- 510(k) Number
- K943728 FDA UDI
- FDA Product Code
- MGQ FDA UDI
- EMDN Code
- M0408 DRESSINGS FOR BURNS ONLY EUDAMED
- GMDN Term
- Synthetic polymer burn dressing, gel-coated FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIWidth — 0.5 Millimeter FDA UDI
Burnshield by Burnshield (pty) Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06007645001434 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Burnshield (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000018376
- Authorised Representative
- Burnshield Europe B.V. NL-AR-000014621
Sources (2)
- EUDAMED 6b940f60-bc26-45dc-9ac8-1f3a1213cd3a 61 fields · synced Jul 10, 2026
- FDA UDI e1654949-2baf-4309-ac42-b6fdce0c0329 38 fields · synced May 30, 2026