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multi-purpose Medium size
EUDAMEDClass I (EU MDR)
Ref /Model ABFX06Model C502B0
Identity
- Trade Name
- multi-purpose Medium size EUDAMED
- Device Name
- multi-purpose Medium size EUDAMEDReusable Hot/cold packs EUDAMED
- Model / Reference
- ABFX06 EUDAMED/ EUDAMEDC502B0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589092305 EUDAMED05706214001752 EUDAMED
- Basic UDI-DI
- B-06973589092305 EUDAMED697358909HP100MD EUDAMED
- Direct Marketing DI
- 05706214001752 EUDAMED06973589092305 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
multi-purpose Medium size by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
- PRONTO MED — Eurosirel Spa · Class IIa
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- ACCU-THERM — Medline Industries, LP · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- ACCU-THERM — Medline Industries, LP · Class I
- Krioboost — EURONDA S.P.A. · Class IIa
- PRONTO DOC — Eurosirel Spa · Class IIa
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-06973589092305 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973589092305 | 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 2fee5081-6ffb-407f-a9ef-898de12dfff7 61 fields · synced Oct 5, 2026
- EUDAMED 1ee2ce0c-d582-4272-a506-b178b3d87f32 61 fields · synced May 17, 2026
- EUDAMED f84a635f-d706-46db-91e8-a9547ea02e58 61 fields · synced May 18, 2026