Identity
- Trade Name
- CU - RT Oyster White EUDAMED
- Device Name
- Rollator Carbon range EUDAMED
- Model / Reference
- 05713504000456 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713504000456 EUDAMED
- Basic UDI-DI
- 5713504000661UG EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Category: Walking chair, non-foldable
CU - RT Oyster White by by ACRE Aps — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Walking chair, non-foldable.
- AND. KAMALEON KIT/PGO V. ESMER. — FABRICACIONES ORTOPEDICAS ALBACETE, S.L. · Class I
- WALKER — CHANGSHA ANWEI ELECTRONIC COMMERCE CO., LTD. · Class I
- AND. AIRON ZERO PGO NEGRO — FABRICACIONES ORTOPEDICAS ALBACETE, S.L. · Class I
- Rollator Walker — GuangDong Dakseon Medical Device Co., Ltd. · Class I
- trio B Gehwagen — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KG · Class I
- Trionic Veloped 12er L — Trionic Sverige AB · Class I
- rollator — Guanchi Technology (Hebei) Co., Ltd. · Class I
- Rollator — Caremaster Technology (HK) Group Co., Ltd · Class I
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 | 5713504000661UG | Class I | Active |
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Manufacturer
- Manufacturer
- by ACRE Aps
- EUDAMED SRN
- DK-MF-000010025
Sources (1)
- EUDAMED ebdcb810-fb03-4991-9129-142fee99c99e 61 fields · synced Jul 22, 2026