Forclaz FAK 100
- Risk class
- Class I
- CND nomenclatures code
- V0501
- Trade name
- Forclaz FAK 100
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 03583787628232
- Basic UDI
- B-03583787628232
- 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 Forclaz FAK 100 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 03583787628232 and manufactured by RFX+CARE Manufacturing Co., Ltd. in China.
This page provides complete registration details including trade name (Forclaz FAK 100), 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.