Identity
- Device Name
- hot cold compress gel ice packs EUDAMED
- Model / Reference
- 3000000000915 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979823830016 EUDAMED
- Basic UDI-DI
- 697982383HL012P2 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
hot cold compress gel ice packs by Hefei Heenlong Trading 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 | 697982383HL012P2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hefei Heenlong Trading Co., Ltd.
- EUDAMED SRN
- CN-MF-000052088
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED b5fe0c8b-2e9b-4f56-b16d-de7e16d37fed 61 fields · synced Jun 19, 2026