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Homecare bed
EUDAMEDFDA UDIClass I (EU MDR)
Ref HB100 、HB200、HB300、FHSY01、HB301、HB302、HB303、HB304、HB305、HB306、HB307、HB308、HB309、HB310、HB311、HB312、HB313
Identity
- Trade Name
- Hi-Fortune FDA UDI
- Generic Name
- Assistive scooter, foot-propelled FDA UDI
- Device Name
- Homecare bed EUDAMEDWeight: 7.8kg, L570mm*W390mm*H985mm FDA UDI
- Model / Reference
- HB100 、HB200、HB300、FHSY01、HB301、HB302、HB303、HB304、HB305、HB306、HB307、HB308、HB309、HB310、HB311、HB312、HB313 EUDAMEDHR-111-02 FDA UDI
- Description
- Weight: 7.8kg, L570mm*W390mm*H985mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973852590064 EUDAMEDFDA UDI
- Basic UDI-DI
- 697385259HbedYS EUDAMED
- Direct Marketing DI
- 06973852590064 EUDAMED
- FDA Product Code
- KNL FDA UDI
- EMDN Code
- V08060101,V08060102,V08060103,V08060104,V08060105,V08060106,V0806010701,V0806010702,V08060199 EUDAMED
- GMDN Term
- Assistive scooter, foot-propelled FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 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
Homecare bed 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 | 697385259HbedYS | 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 bae12151-eda5-46a8-9005-120fe1e80efb 61 fields · synced Jun 19, 2026
- FDA UDI ff0e24b1-83ff-49ef-a8f8-c768de2c9794 33 fields · synced May 29, 2026