Identity
- Device Name
- Ice pack EUDAMED
- Model / Reference
- 180G EUDAMEDN/A EUDAMED160G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958689900566 EUDAMED16958689900573 EUDAMED
- Basic UDI-DI
- 69586899IP00100027M EUDAMED69586899IP00100037P EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Ice pack by Pujiang Jianyu Sanitary Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69586899IP00100027M | Class I | Active |
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Manufacturer
- Manufacturer
- Pujiang Jianyu Sanitary Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000043742
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a808ac57-5e3e-4b27-bc1a-9b2978453dfe 61 fields · synced Jul 26, 2026
- EUDAMED 35551fb9-2516-4ad6-bbea-5a0ede50eb64 61 fields · synced May 18, 2026