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Electronic lift
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY101、HY201、HY118、 HY302、HY601、 HY603、 HY320、HY321、 HY322 、HY323、 HY324、 HY325 、HY326 、HY327、 HY328 、HY329Ref HM303DModel HM303D、HM302、HM305、HM308、HM306、HM03MS、HM310、HM311、HM312、HM313、HM314、HM315、HM316、HM317、HM318、HM319
Identity
- Trade Name
- Hi-Fortune FDA UDI
- Generic Name
- All-plastic conventional wheelchair FDA UDI
- Device Name
- Electronic lift EUDAMEDManual wheelchair EUDAMEDWeight: 10.5kg, L770mm*W325mm*H760mm FDA UDI
- Model / Reference
- HY101、HY201、HY118、 HY302、HY601、 HY603、 HY320、HY321、 HY322 、HY323、 HY324、 HY325 、HY326 、HY327、 HY328 、HY329 EUDAMEDHM303D、HM302、HM305、HM308、HM306、HM03MS、HM310、HM311、HM312、HM313、HM314、HM315、HM316、HM317、HM318、HM319 EUDAMEDHM303D EUDAMEDFDA UDI
- Description
- Weight: 10.5kg, L770mm*W325mm*H760mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973852590033 EUDAMEDFDA UDI06973852593034 EUDAMED
- Basic UDI-DI
- 697385259Elift8Q EUDAMED697385259MwheelchairGV EUDAMED
- Direct Marketing DI
- 06973852590033 EUDAMED
- FDA Product Code
- IMN FDA UDI
- EMDN Code
- V080502 PATIENT TRANSFER CHAIRS EUDAMEDY122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- All-plastic conventional wheelchair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Market of Registration
- Austria EUDAMEDDenmark 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 (3)
- EUDAMED a4157f7f-d33d-46ee-bb48-2792854ea064 61 fields · synced Oct 7, 2026
- EUDAMED f77c47b1-f5a0-4f26-9291-026d89a6938f 61 fields · synced May 18, 2026
- FDA UDI 4ebb9917-4846-499f-a7ac-a5eca8134531 33 fields · synced May 30, 2026