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Rollator
EUDAMEDClass I (EU MDR)
Ref RM4131 Model RM4131/RF4101/RM4132/RM4133/RM4133/RM4231/RM4232/RM4233/RM4331/RM4332/RM4333/RM4431/RM4432/RM4433/RM4531/RM4532/RM4533 etc
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- RM4131/RF4101/RM4132/RM4133/RM4133/RM4231/RM4232/RM4233/RM4331/RM4332/RM4333/RM4431/RM4432/RM4433/RM4531/RM4532/RM4533 etc EUDAMEDRM4131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961463507 EUDAMED
- Basic UDI-DI
- 471996146Rollator01HY EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER 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
Category: Walking chair, non-foldable
Rollator by Innovation Space Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Walking chair, non-foldable.
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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 | 471996146Rollator01HY | Class I | Active |
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Manufacturer
- Manufacturer
- Innovation Space Technology Co., Ltd
- EUDAMED SRN
- TW-MF-000045902
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0bc9892d-8f26-405a-83bf-175f29ff29a9 61 fields · synced Jun 18, 2026