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Rollator
EUDAMEDFDA UDIClass I (EU MDR)
Ref NIP 、HR200、 HR201、 HR202、 HR203、 HR101、 HR204 、HR205、 HR206、 HR207、 HR208、 HR209、 HR210 、HR211、 HR212 、HR213
Identity
- Trade Name
- Hi-Fortune FDA UDI
- Generic Name
- Chair lift/transporter FDA UDI
- Device Name
- Rollator EUDAMEDWeight: 39kg, L820mm*W720mm*H550mm FDA UDI
- Model / Reference
- NIP 、HR200、 HR201、 HR202、 HR203、 HR101、 HR204 、HR205、 HR206、 HR207、 HR208、 HR209、 HR210 、HR211、 HR212 、HR213 EUDAMEDTLS-200 FDA UDI
- Description
- Weight: 39kg, L820mm*W720mm*H550mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973852590057 EUDAMEDFDA UDI
- Basic UDI-DI
- 697385259RollatorHM EUDAMED
- Direct Marketing DI
- 06973852590057 EUDAMED
- FDA Product Code
- FNG FDA UDI
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
- GMDN Term
- Chair lift/transporter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5500 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rollator by Kunshan Hi-Fortune Health Products 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 | 697385259RollatorHM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kunshan Hi-Fortune Health Products Co., Ltd
- EUDAMED SRN
- CN-MF-000035403
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED b3d53ce4-ed3e-468f-9426-da3d2607b52a 61 fields · synced Oct 6, 2026
- FDA UDI b1a76497-9be0-457e-9102-980fb077b376 33 fields · synced May 30, 2026