Identity
- Trade Name
- ROTHBAND EUDAMED
- Device Name
- X-RAY PROTECTION TOP EUDAMED
- Model / Reference
- TXR EUDAMEDKXR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05057326003401 EUDAMED
- Basic UDI-DI
- 5057326APRONSV5 EUDAMED
- EMDN Code
- Y090699 DEVICES FOR BODY PROTECTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Rothband by W S R Medical Solutions Ltd — 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 | 5057326APRONSV5 | Class I | Active |
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Manufacturer
- Manufacturer
- WSR Medical Solutions Ltd
- EUDAMED SRN
- GB-MF-000017973
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 5ab2bf0b-4637-4f71-a7dc-70c6939b3b42 61 fields · synced Jun 18, 2026