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JosonCare
EUDAMEDFDA UDIClass I (EU MDR)
Ref ES SeriesModel ES-12HD, ES-12DF, ES-11HD, ES-96HD, ES-05HD, ES-99HDS
Identity
- Trade Name
- JosonCare EUDAMEDJoson-Care FDA UDI
- Generic Name
- Basic electric hospital bed FDA UDI
- Model / Reference
- ES-12HD, ES-12DF, ES-11HD, ES-96HD, ES-05HD, ES-99HDS EUDAMEDES Series EUDAMEDES-05HD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873200368 EUDAMED04719873200139 EUDAMED04719873200023 EUDAMEDFDA UDI04719873200054 EUDAMED
- Basic UDI-DI
- 471987320Electricbedk2A5 EUDAMED
- FDA Product Code
- FNL FDA UDI
- EMDN Code
- V08060101 HOSPITAL/HOME CARE ELECTRIC MEDICAL BEDS EUDAMED
- GMDN Term
- Basic electric hospital bed FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5100 FDA UDI
- Market of Registration
- Netherlands 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic electric hospital bed
JosonCare by Joson-Care Enterprise Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 471987320Electricbedk2A5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joson-Care Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000031956
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (5)
- EUDAMED 0b1443c6-60da-486b-8a9b-20eeaa63048d 61 fields · synced Jul 20, 2026
- EUDAMED 30bcebba-dd06-4d31-b315-759169bfe42c 61 fields · synced May 17, 2026
- EUDAMED cea66e55-1369-4493-8ac4-31769aa662f3 61 fields · synced May 17, 2026
- EUDAMED 96057583-db6d-4d72-a081-58703a383679 61 fields · synced May 17, 2026
- FDA UDI a2eb0379-60a9-431e-8eef-d4f9a2cfd390 33 fields · synced May 30, 2026