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Reusable hot/cold pack for multi purpose
EUDAMEDClass I (EU MDR)
Ref AGWB14Model C502B0Ref Extra Large Hip Ice PackRef /Model AGHK01Model AMRD01
Identity
- Trade Name
- Reusable hot/cold pack for multi purpose EUDAMEDExtra Large Hip Ice Pack EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMEDExtra Large Hip Ice Pack EUDAMED
- Model / Reference
- C502B0 EUDAMEDAGWB14 EUDAMEDExtra Large Hip Ice Pack EUDAMEDAGHK01 EUDAMED/ EUDAMEDAMRD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920970526 EUDAMED06973589092206 EUDAMED06978920971363 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMEDB-06973589092206 EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970526 EUDAMED06973589092206 EUDAMED06978920971363 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 hot/cold pack for multi purpose by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697358909HP100MD | Class I | Active |
| 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 (5)
- EUDAMED e6f45604-79df-4e82-a73a-36beea413b37 61 fields · synced Jul 10, 2026
- EUDAMED 3b86c372-c724-422b-9ab4-9abeb354170b 61 fields · synced May 17, 2026
- EUDAMED 4fbcea02-b6fb-4102-9c77-72dc0884347b 61 fields · synced May 17, 2026
- EUDAMED ab0b3dfe-0d34-49d8-804d-21520391824c 61 fields · synced Jul 10, 2026
- EUDAMED 04f8dd33-42b1-481f-9ad4-5aa4332ec927 61 fields · synced Jul 10, 2026