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Hot Pack
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref N/AModel YS-NSD25,YS-NSD35,YS-NSD40,YS-NSD60,YS-NSD63,YS-NSD65,YS-NSD70,YS-NSD75,YS-NSD80,YS-NSD90,YS-NSD100,YS-NSD110,YS-NSD600,YS-NSD1000
Identity
- Trade Name
- Hot Pack EUDAMEDFDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- Hot Pack EUDAMED
- Model / Reference
- YS-NSD25,YS-NSD35,YS-NSD40,YS-NSD60,YS-NSD63,YS-NSD65,YS-NSD70,YS-NSD75,YS-NSD80,YS-NSD90,YS-NSD100,YS-NSD110,YS-NSD600,YS-NSD1000 EUDAMEDN/A EUDAMEDYS-NSD50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975551433154 EUDAMEDFDA UDI
- Basic UDI-DI
- 6975551432023032026024CR EUDAMED
- FDA Product Code
- IME FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Hot/cold therapy pack, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5700 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hot Pack by Jiangsu Yishun Medical Equipment Co., LTD — Class IIa — 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 | 6975551432023032026024CR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Yishun Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000030036
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 40428b93-3c6c-4d4e-a452-272ee9657d03 61 fields · synced Oct 6, 2026
- FDA UDI e62ab99d-7269-49b0-ba3c-60a9b4f7b374 32 fields · synced May 30, 2026
- EUDAMED 40428b93-3c6c-4d4e-a452-272ee9657d03-1 61 fields · synced Jun 9, 2026