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Hot/cold pack / Ice packs / Reusable gel pack / Reusable instant ice pack / Coo…
EUDAMEDClass I (EU MDR)
Ref HG-IP04Model HG-RP01, HG-RP02, HG-RP03, HG-RP04, HG-IP01, HG-IP02, HG-IP03, HG-IP04, HG-IP05, HG-IP06, HG-IP07, HG-IP08, HG-IP09, HG-IP10, HG-IP11, HG-IP12, HG-IP13, HG-IP14, HG-IP15, HG-IP16, HG-IP17, HG-IP18
Identity
- Device Name
- Hot/cold pack / Ice packs / Reusable gel pack / Reusable instant ice pack / Cooling gel patch EUDAMED
- Model / Reference
- HG-RP01, HG-RP02, HG-RP03, HG-RP04, HG-IP01, HG-IP02, HG-IP03, HG-IP04, HG-IP05, HG-IP06, HG-IP07, HG-IP08, HG-IP09, HG-IP10, HG-IP11, HG-IP12, HG-IP13, HG-IP14, HG-IP15, HG-IP16, HG-IP17, HG-IP18 EUDAMEDHG-IP04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976543670595 EUDAMED
- Basic UDI-DI
- 697654367IcepacksYU EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Hot/cold pack / Ice packs / Reusable gel pack / Reusable instant ice pack / Coo… by Hangzhou Weize Imp & Exp Co., Ltd. — Class I — MDR — listed in EUDAMED
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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 | 697654367IcepacksYU | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Weize Imp & Exp Co., Ltd.
- EUDAMED SRN
- CN-MF-000036544
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d2e26f94-0fa3-475a-9002-404d32730f7d 61 fields · synced Jul 19, 2026