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Rollator
EUDAMEDFDA UDIClass I (EU MDR)
Ref W2301Model W2301,W2306,W2501,W2307,W2308,W2308,W2308A,W2309, W2502,W2503,W2505Model W2301 W2501 W2502 W2503 W2505 W2306 W2307 W2308 W2308A W2309
Identity
- Trade Name
- Rollator EUDAMEDFDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- Rollator EUDAMED
- Model / Reference
- W2301,W2306,W2501,W2307,W2308,W2308,W2308A,W2309, W2502,W2503,W2505 EUDAMEDW2301 EUDAMEDFDA UDIW2301 W2501 W2502 W2503 W2505 W2306 W2307 W2308 W2308A W2309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978949462385 EUDAMED06970765974004 EUDAMED06978949461548 FDA UDI
- Basic UDI-DI
- 697894946RL001WC EUDAMED697076597ROLLATOR001A7 EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120606 WHEELED WALKER EUDAMEDY120612 WALKING TROLLEYS EUDAMED
- GMDN Term
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3825 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Walking chair, non-foldable
Rollator by Zhejiang Innuovo Rehabilitation Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Walking chair, non-foldable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697894946RL001WC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000008727
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 65707002-3419-46bc-974f-3e8f6b08a882 61 fields · synced Jul 12, 2026
- EUDAMED 5fa86cf7-4133-4f81-8f89-e6c09c0adacb 61 fields · synced May 17, 2026
- FDA UDI 34ddc96a-99f2-45c6-91f5-559d93d1154f 32 fields · synced May 26, 2026