Cold /Hot pack
- Risk class
- Class I
- CND nomenclatures code
- Z120602
- Trade name
- Hot/cold reusable compress
- Implantable
- No
- Reusable
- Yes
- Measuring function
- No
- Primary DI
- 03608390946419
- Basic UDI
- 69228209MDN1214IN0000145Q
- Version date
- March 03, 2025
- Manufacturer last update
- August 16, 2024
- Active status
- No
- Manufacturer name
- RFX+CARE Manufacturing Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No.599-1F Wuxie Road, Yuecheng District, Shaoxing, Zhejiang, China 312000 Shaoxing
- benjamin@rfx-care.com
- SRN
- DK-AR-000001768
- Country
- Denmark
- Address
- 22B Gammel Strandvej Nivå
- info@rfxcare.com
- Telephone
- +45 45769020
- Competent authority
- Danish Medicines Agency, Pharmacovigilance & Medical Devices
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- France
- Human tissues
- No
- Animal tissues
- No
PHYSIOTHERAPY EQUIPMENT
Access comprehensive regulatory information for Cold /Hot pack in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 03608390946419 and manufactured by RFX+CARE Manufacturing Co., Ltd. in China.
This page provides complete registration details including trade name (Hot/cold reusable compress), manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.