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Reusable gel compress for ankle
EUDAMEDClass I (EU MDR)
Ref ACJH09Model C502B0Model AMRD01
Identity
- Trade Name
- Reusable gel compress for ankle EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMED
- Model / Reference
- C502B0 EUDAMEDACJH09 EUDAMEDAMRD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920970779 EUDAMED06978920971110 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970779 EUDAMED06978920971110 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
Reusable gel compress for ankle by Wuhan Pakcare Bio‐technology 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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- Kit de cryothérapie périnéale règles douloureuses — ORTHOMEDICA · 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 | 697358909HP100MD | 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 (3)
- EUDAMED 2ca98dc1-809c-44ec-a943-7fba9bf7166e 61 fields · synced Jul 19, 2026
- EUDAMED bcb23d39-7797-4f00-8395-45f9b51495b5 61 fields · synced Jul 13, 2026
- EUDAMED aef757bc-82c4-454d-ac7a-ef90f9532a11 61 fields · synced Jul 19, 2026