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Walking Aids, Rollator
EUDAMEDClass I (EU MDR)
Ref TWA9635LModel TWA9127L,TWA004,TWA009,THE965L,TWA965LH,TWA965LH-1,TWA965LH-A,THE965LF1,TWA9650LH,TWA965LH-B,TWA965LHF1,TWA966LH,TWA966LH-B, etc
Identity
- Trade Name
- WALKING AIDS, ROLLATOR EUDAMED
- Device Name
- WALKING AIDS, ROLLATOR EUDAMED
- Model / Reference
- TWA9127L,TWA004,TWA009,THE965L,TWA965LH,TWA965LH-1,TWA965LH-A,THE965LF1,TWA9650LH,TWA965LH-B,TWA965LHF1,TWA966LH,TWA966LH-B, etc EUDAMEDTWA9635L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974387622299 EUDAMED
- Basic UDI-DI
- 697438762TWA001UZ EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Walking Aids, Rollator by Guangzhou Topmedi Co., Ltd. — 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
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- 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 | 697438762TWA001UZ | Class I | Active |
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Manufacturer
- Manufacturer
- Guangzhou Topmedi Co., Ltd.
- EUDAMED SRN
- CN-MF-000016883
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 04d61cc5-44e2-4df7-be36-dc0a21512521 61 fields · synced Jun 18, 2026