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Frozen Ice Pack
EUDAMEDClass I (EU MDR)
Ref YS-BDA50Model YS-BDA50,YS-BDA100,YS-BDA150,YS-BDA200,YS-BDA250,YS-BDA500,YS-BDB50,YS-BDB100,YS-BDB150,YS-BDB200,YS-BDB250,YS-BDB500,YS-BDC50,YS-BDC100,YS-BDC150,YS-BDC200,YS-BDC250,YS-BDC500,etc.
Identity
- Device Name
- Frozen Ice Pack EUDAMED
- Model / Reference
- YS-BDA50,YS-BDA100,YS-BDA150,YS-BDA200,YS-BDA250,YS-BDA500,YS-BDB50,YS-BDB100,YS-BDB150,YS-BDB200,YS-BDB250,YS-BDB500,YS-BDC50,YS-BDC100,YS-BDC150,YS-BDC200,YS-BDC250,YS-BDC500,etc. EUDAMEDYS-BDA50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975551437008 EUDAMED
- Basic UDI-DI
- 697555143IcePackQX EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Hot/cold therapy pack, reusable
Frozen Ice Pack by Jiangsu Yishun Medical Equipment Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697555143IcePackQX | Class I | Active |
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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 (1)
- EUDAMED e4e77d99-5448-4e6d-891b-690ecca50cfc 61 fields · synced Jun 19, 2026