Identity
- Trade Name
- BRMED EUDAMED
- Device Name
- DISPOSABLE OVERALLS - SMS EUDAMED
- Model / Reference
- BRTLM-003 EUDAMEDWBRTLM-003XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683036263117 EUDAMED
- Basic UDI-DI
- 868303626BRTLM-003K6 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Brmed by Brben Teksti̇l Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 868303626BRTLM-003K6 | Class I | Active |
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Manufacturer
- Manufacturer
- Brben Teksti̇l Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000021341
Sources (1)
- EUDAMED e37babb6-020d-4536-8a76-f088fd3ac722 61 fields · synced Jun 18, 2026