Identity
- Trade Name
- Burnisher EUDAMED
- Device Name
- Burnisher EUDAMED
- Model / Reference
- BURNISHER EUDAMEDCT-BB27/293 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G399CTBB272930Z EUDAMED
- Basic UDI-DI
- ++G399BURNISHERYJ EUDAMED
- Direct Marketing DI
- +G399CTBB272930Z EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The Burnisher medical device is a Class I-rated, self-testing, sterile device used for burn management in high-acuity settings. It features a unique sterilization process and is designed for quick and efficient application of treatment to minimize trauma and promote healing.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G399BURNISHERYJ | Class I | Active |
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Manufacturer
- Manufacturer
- Crosstex (private) Limited.
- EUDAMED SRN
- PK-MF-000032784
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 03ab5b68-d23b-4122-8ef7-bbcae450bedc 61 fields · synced Jul 12, 2026