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Medical Gel Ice Pack
EUDAMEDClass I (EU MDR)
Ref HM-01(FACE)Model HM-01(FACE),HS-01(ARM),HT-01(LEG),HH-01 (FOOT),HJ-01(NECK),HJ-01(SHOULDER),HB-01(BACK), HS-01(HAND),3701,3702,3703,3704,3705,3706,3707,3708,3709, OR CUSTOMIZED
Identity
- Device Name
- MEDICAL GEL ICE PACK EUDAMED
- Model / Reference
- HM-01(FACE),HS-01(ARM),HT-01(LEG),HH-01 (FOOT),HJ-01(NECK),HJ-01(SHOULDER),HB-01(BACK), HS-01(HAND),3701,3702,3703,3704,3705,3706,3707,3708,3709, OR CUSTOMIZED EUDAMEDHM-01(FACE) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936047303702 EUDAMED
- Basic UDI-DI
- 69360473GELICEPACK2E 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
Medical Gel Ice Pack by Yangzhou Aolikes Sports Goods 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 | 69360473GELICEPACK2E | Class I | Active |
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Manufacturer
- Manufacturer
- Yangzhou Aolikes Sports Goods Co., Ltd.
- EUDAMED SRN
- CN-MF-000049566
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED f87042aa-bd2c-49a6-9b6c-2a7b8dcae779 61 fields · synced Jun 18, 2026