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Rollator
EUDAMEDFDA UDIClass I (EU MDR)
Ref Z51Model Z11、Z12、Z13、Z14、Z15、Z16、Z17、Z18、Z19、Z21、Z22、Z23、Z25、Z26、Z27 etc
Identity
- Trade Name
- VOCIC FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- Rollator EUDAMED
- Model / Reference
- Z11、Z12、Z13、Z14、Z15、Z16、Z17、Z18、Z19、Z21、Z22、Z23、Z25、Z26、Z27 etc EUDAMEDZ51 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975960551401 EUDAMEDFDA UDI
- Basic UDI-DI
- 697596055R01UH EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120612 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
- Germany 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rollator by Zhejiang Mateside Medical Devices Technology Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697596055R01UH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000047001
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED e066eab3-dd5a-46bc-b4d9-5267ff7cb2ef 61 fields · synced Jul 31, 2026
- FDA UDI be7c5e75-0282-4507-8074-0cf2bb5d7885 32 fields · synced May 29, 2026