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Hot & Cold Gel Compress XL
EUDAMEDClass I (EU MDR)
Ref AGFX27Model C502B0Ref /Model AMRD01
Identity
- Trade Name
- Hot & Cold Gel Compress XL EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMEDHot & Cold Gel Compress XL EUDAMED
- Model / Reference
- C502B0 EUDAMEDAGFX27 EUDAMED/ EUDAMEDAMRD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589091254 EUDAMED06978920971264 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMEDB-06973589091254 EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06973589091254 EUDAMED06978920971264 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 Gel Compress XL 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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- PRONTO DOC — Eurosirel Spa · Class IIa
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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 (3)
- EUDAMED 91ba9bc8-423c-4fd2-a173-24bd51c96236 61 fields · synced Jul 24, 2026
- EUDAMED d6bdd9c2-bcbf-4b8c-9724-166e3ecf6dcc 61 fields · synced May 18, 2026
- EUDAMED 7378a782-e263-440c-b327-81ca2f83d1f3 61 fields · synced Jul 24, 2026