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Minerva Pro / Parafleet SC 018 PTA Balloon Dilatation Catheter - EUDAMED Registration 06942265508423

Access comprehensive regulatory information for Minerva Pro / Parafleet SC 018 PTA Balloon Dilatation Catheter in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06942265508423 and manufactured by BrosMed Medical Co., Ltd in China.

This page provides complete registration details including trade name (Parafleet SC 018), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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 IIa
06942265508423
No
Minerva Pro / Parafleet SC 018 PTA Balloon Dilatation Catheter
Trade Name: Parafleet SC 018
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Device Description (EMDN)

PTA BALLOON DILATATION CATHETERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
C010402020101
Trade Name
Parafleet SC 018
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06942265508423
Basic UDI
695848140064MH
Active Status
No
Manufacturer
Manufacturer Name
BrosMed Medical Co., Ltd
Country
China
Country Type
NON_EU
Address
15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone Dongguan, Guangdong
Email
bmregulatory@brosmed.com
Authorized Representative
SRN
NL-AR-000002616
Country
Netherlands
Address
Mgr. Buckxstraat 8, 6134 AP Sittard Sittard
Email
bvregulatory@brosmed.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Market Available
Netherlands:2023-03-10~2028-03-09
Device Characteristics
Human Tissues
No
Animal Tissues
No