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Cold pack
EUDAMEDClass IIa (EU MDR)
Ref N/AModel CP200Ref AGYX02Model C502B0Model AMRD01
Identity
- Trade Name
- COLD PACK -GEL PACK EUDAMED
- Device Name
- Cold pack EUDAMEDReusable Hot/cold packs EUDAMED
- Model / Reference
- CP200 EUDAMEDN/A EUDAMEDC502B0 EUDAMEDAGYX02 EUDAMEDAMRD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589091056 EUDAMED06978920970342 EUDAMED
- Basic UDI-DI
- B-06973589091056 EUDAMED697358909HP100MD EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970342 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
Cold pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class IIa — MDR, MDD — 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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06973589091056 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06973589091056 | Class IIa | 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 8a37374c-05dd-4d22-a404-39ae919d9a37 61 fields · synced Jul 26, 2026
- EUDAMED a1db568b-4db9-4384-8aa5-06792ef6a618 61 fields · synced May 18, 2026
- EUDAMED 16020e4d-7aba-4b58-81b9-b2841141a9b7 61 fields · synced Jun 18, 2026