Refill FAK
- Risk class
- Class I
- CND nomenclatures code
- V0501
- Trade name
- Refill FAK
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 03583787628256
- Basic UDI
- B-03583787628256
- Version date
- March 04, 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
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- France
- Human tissues
- No
- Animal tissues
- No
CLINICAL EMERGENCY KITS
Access comprehensive regulatory information for Refill FAK 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 03583787628256 and manufactured by RFX+CARE Manufacturing Co., Ltd. in China.
This page provides complete registration details including trade name (Refill FAK), 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.