Identity
- Trade Name
- HOT OR COLD GEL PACK EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMED
- Model / Reference
- AMRD01 EUDAMEDAGFX34 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920972834 EUDAMED
- Basic UDI-DI
- 697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920972834 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
Hot Or Cold Gel Pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697892097HP100Q6 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 05cb05d6-6ca5-4c5c-9a8b-d9431d755aaf 61 fields · synced Jun 19, 2026