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Multi function cold hot pack
EUDAMEDClass I (EU MDR)
Ref AGTZ04Model C502B0Ref /Model AMRD01
Identity
- Trade Name
- Multi function cold hot pack EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMEDMulti function cold hot pack EUDAMED
- Model / Reference
- C502B0 EUDAMEDAGTZ04 EUDAMED/ EUDAMEDAMRD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589093180 EUDAMED06978920971349 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMEDB-06973589093180 EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06973589093180 EUDAMED06978920971349 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
Multi function cold hot pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 1d5d1fe0-af97-437c-8c39-2c2514365e63 61 fields · synced Oct 6, 2026
- EUDAMED 86779a9b-ebd1-4f69-ada6-ea545448e14b 61 fields · synced May 19, 2026
- EUDAMED c1aec70e-797f-4ae3-b704-7d9cf05d9d24 61 fields · synced Jul 9, 2026