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Medical gel ice pack
EUDAMEDClass I (EU MDR)
Ref HM-1(FACE)Model HM-1(FACE),HS-1(ARM),HT-1(LEG),HH-1(FOOT),HJ-1(NECK),HJ-1(SHOULDER),HB-1(BACK),HS-1(HAND),OR CUSTOMIZED
Identity
- Device Name
- Medical gel ice pack EUDAMED
- Model / Reference
- HM-1(FACE),HS-1(ARM),HT-1(LEG),HH-1(FOOT),HJ-1(NECK),HJ-1(SHOULDER),HB-1(BACK),HS-1(HAND),OR CUSTOMIZED EUDAMEDHM-1(FACE) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977986480000 EUDAMED
- Basic UDI-DI
- 697798648MGIP2X 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 Jiangsu Maiha New Materials 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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- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 | 697798648MGIP2X | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Maiha New Materials Co. , Ltd.
- EUDAMED SRN
- CN-MF-000044772
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED dc5a06fd-8925-48aa-bff7-e944ce68f3e1 61 fields · synced Jun 18, 2026