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Rollator
EUDAMEDFDA UDIClass I (EU MDR)
Ref V-RL-Z51-E-BKModel Z52、Z71、Z62、V-RL-Z31-E-RD、V-RL-Z31-E-BL、V-RL-Z31-E-SV、V-RL-Z31-E-BK、V-RL-Z51-E-BK、V-RL-Z55-E-RD、V-RL-Z55-E-BK、V-RL-Z55-E-BL、Z55、V-RL-Z63-E-BK、V-RL-Z63-E-BG、V-RL-Z22-E-BL、Z22
Identity
- Trade Name
- maidesite FDA UDI
- Generic Name
- Alternating-pressure bed mattress FDA UDI
- Device Name
- Rollator EUDAMED
- Model / Reference
- Z52、Z71、Z62、V-RL-Z31-E-RD、V-RL-Z31-E-BL、V-RL-Z31-E-SV、V-RL-Z31-E-BK、V-RL-Z51-E-BK、V-RL-Z55-E-RD、V-RL-Z55-E-BK、V-RL-Z55-E-BL、Z55、V-RL-Z63-E-BK、V-RL-Z63-E-BG、V-RL-Z22-E-BL、Z22 EUDAMEDV-RL-Z51-E-BK EUDAMEDS12VA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976062570130 EUDAMEDFDA UDI
- Basic UDI-DI
- 697606257rollatorT6 EUDAMED
- FDA Product Code
- FNM FDA UDI
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
- GMDN Term
- Alternating-pressure bed mattress FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5550 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Rollator by Hangzhou Guoyuan Yanglao 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 | 697606257rollatorT6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Guoyuan Yanglao Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000034777
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ae6bb476-34d4-42be-89fd-993ff8971a8a 61 fields · synced Jul 25, 2026
- FDA UDI 3383b9b1-e82c-4fb9-a780-05105695df3f 33 fields · synced May 30, 2026