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Compression Back Ice Pack Wrap
EUDAMEDClass I (EU MDR)
Ref /Model AMHY02Model C502B0
Identity
- Trade Name
- Reusable Airbag hot or cold pack for lower back EUDAMED
- Device Name
- Compression Back Ice Pack Wrap EUDAMEDReusable Hot/cold packs EUDAMED
- Model / Reference
- AMHY02 EUDAMED/ EUDAMEDC502B0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589091728 EUDAMED
- Basic UDI-DI
- B-06973589091728 EUDAMED697358909HP100MD EUDAMED
- Direct Marketing DI
- 06973589091728 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
Compression Back Ice Pack Wrap by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06973589091728 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973589091728 | 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 (2)
- EUDAMED 107cfb46-c165-487b-b38c-a4a9646104e2 61 fields · synced Oct 8, 2026
- EUDAMED f330a202-1199-4bea-850d-533d2a8f6a1e 61 fields · synced May 19, 2026