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Reusable Hot/Cold Pack
EUDAMEDClass I (EU MDR)
Ref AGTY06Model C502B0Ref ABTY01Ref AGTZ15Ref ASCF01Model AMRD01
Identity
- Trade Name
- Reusable Hot/Cold Pack EUDAMEDReusable Hot/cold packs EUDAMEDReusable hot cold pack - perineal pack EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMED
- Model / Reference
- C502B0 EUDAMEDAGTY06 EUDAMEDABTY01 EUDAMEDAGTZ15 EUDAMEDASCF01 EUDAMEDAMRD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920970991 EUDAMED06978920971035 EUDAMED06978920971028 EUDAMED06978920970977 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920970991 EUDAMED06978920971035 EUDAMED06978920971028 EUDAMED06978920970977 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMEDBelgium 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 by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (8)
- EUDAMED eb181db3-acee-47d8-9542-47b78f1d4f33 61 fields · synced Oct 6, 2026
- EUDAMED 92c78e25-386c-498f-80cb-7be919c90ec8 61 fields · synced May 16, 2026
- EUDAMED 8175283c-d98f-42ea-9711-6b88d0252997 61 fields · synced May 17, 2026
- EUDAMED bc517440-9fca-4dba-aea7-2a61cbc7dec4 61 fields · synced May 18, 2026
- EUDAMED 776e0241-3b26-4b03-8e21-dc3adbf420d4 61 fields · synced Jul 9, 2026
- EUDAMED a9b6a2ea-2d3c-4d87-9abf-a6523c829594 61 fields · synced Jul 12, 2026
- EUDAMED b586279c-b412-4f95-ba6c-7247677a554b 61 fields · synced Jul 12, 2026
- EUDAMED 379949ab-2d3a-47b8-92d9-764a2fa9eb88 61 fields · synced Jul 18, 2026