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Forclaz FAK 100 - EUDAMED Registration 03583787628232

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.

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EUDAMED Official Data
Class I
03583787628232
No
Forclaz FAK 100
Trade Name: Forclaz FAK 100
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Device Description (EMDN)

CLINICAL EMERGENCY KITS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V0501
Trade Name
Forclaz FAK 100
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
03583787628232
Basic UDI
B-03583787628232
Version Date
March 04, 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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No