Pure Global

Cold /Hot pack - EUDAMED Registration 03608390946419

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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
03608390946419
No
Cold /Hot pack
Trade Name: Hot/cold reusable compress
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

PHYSIOTHERAPY EQUIPMENT

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z120602
Trade Name
Hot/cold reusable compress
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
03608390946419
Basic UDI
69228209MDN1214IN0000145Q
Version Date
March 03, 2025
Manufacturer Last Update
August 16, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.599-1F Wuxie Road, Yuecheng District, Shaoxing, Zhejiang, China 312000 Shaoxing
Email
benjamin@rfx-care.com
Authorized Representative
SRN
DK-AR-000001768
Country
Denmark
Address
22B Gammel Strandvej Nivรฅ
Email
info@rfxcare.com
Telephone
+45 45769020
Regulatory Information
Competent Authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No