Atropos Pro / Parafleet SC 035 PTA Balloon Dilatation Catheter
- Risk class
- Class IIa
- CND nomenclatures code
- C010402020101
- Trade name
- Parafleet SC 035
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06942265518712
- Basic UDI
- 695848140065MK
- Active status
- No
- 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
- bmregulatory@brosmed.com
- SRN
- NL-AR-000002616
- Country
- Netherlands
- Address
- Mgr. Buckxstraat 8, 6134 AP Sittard Sittard
- bvregulatory@brosmed.com
- 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
- Human tissues
- No
- Animal tissues
- No
PTA BALLOON DILATATION CATHETERS
Access comprehensive regulatory information for Atropos Pro / Parafleet SC 035 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 06942265518712 and manufactured by BrosMed Medical Co., Ltd in China.
This page provides complete registration details including trade name (Parafleet SC 035), 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.