Identity
- Device Name
- Flexible Roll Board EUDAMED
- Model / Reference
- B-FlexRB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04717048511028 EUDAMED
- Basic UDI-DI
- 471704851B-FlexRBZC EUDAMED
- Direct Marketing DI
- 04717048511028 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Flexible Roll Board by EZ-Care Solution, Co., 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 | 471704851B-FlexRBZC | Class I | Active |
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Manufacturer
- Manufacturer
- EZ-Care Solution, Co., Ltd.
- EUDAMED SRN
- TW-MF-000028166
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED f50a26f7-0d1a-46ee-a527-116b33534ef7 61 fields · synced Jul 16, 2026