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Electronic lift
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY201Model HY101、HY201、HY118、 HY302、HY601、 HY603、 HY320、HY321、 HY322 、HY323、 HY324、 HY325 、HY326 、HY327、 HY328 、HY329
Identity
- Trade Name
- Hi-Fortune FDA UDI
- Generic Name
- Chair lift/transporter FDA UDI
- Device Name
- Electronic lift EUDAMEDWeight: 47kg, L1370mm*W720mm*H360mm FDA UDI
- Model / Reference
- HY101、HY201、HY118、 HY302、HY601、 HY603、 HY320、HY321、 HY322 、HY323、 HY324、 HY325 、HY326 、HY327、 HY328 、HY329 EUDAMEDHY201 EUDAMEDFDA UDI
- Description
- Weight: 47kg, L1370mm*W720mm*H360mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973852591108 EUDAMED06973852590071 FDA UDI
- Basic UDI-DI
- 697385259Elift8Q EUDAMED
- FDA Product Code
- FNG FDA UDI
- EMDN Code
- V080502 PATIENT TRANSFER CHAIRS 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
- 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
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
Electronic lift 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 | 697385259Elift8Q | 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 606688c8-4efd-4f48-ada2-3095fa913215 61 fields · synced Oct 6, 2026
- FDA UDI 6c457173-97d3-492e-a301-b936df1459cf 33 fields · synced May 27, 2026