Pure Global AI
Authorized representative profile

Prolinx GmbH

EU EUDAMEDGermany1489 represented devicesSRN DE-AR-000005129
VerifiedEUDAMED · official EU database
1,489
Total devices
6
Risk classes
2022
Earliest version
2025
Latest version
Regulatory footprint
Search Prolinx GmbH across other regulatory registries
ThailandColombiaSouth KoreaCanadaEcuadorSaudi Arabia
Recent products (latest 10)
Most recently updated devices in the database
Puncture Needle
06938695510822
Class IIa
Puncture Needle
06938695530080
Class IIa
Puncture Needle
06938695510853
Class IIa
Puncture Needle
06938695530011
Class IIa
Puncture Needle
06938695530066
Class IIa
Puncture Needle
06938695510815
Class IIa
Puncture Needle
06938695510846
Class IIa
Puncture Needle
06938695510860
Class IIa
Puncture Needle
06938695510839
Class IIa
Puncture Needle
06938695510808
Class IIa
Risk class distribution
Breakdown by risk classification
Class IIb72248.5% of total
Class IIa66244.5% of total
Class I996.6% of total
Class A40.3% of total
IVD devices for self-testing10.1% of total
IVD Annex II List B10.1% of total
Top manufacturers
Most common manufacturers represented by this AR
Hangzhou Tappa Medical Technology Co , Ltd.
23.5%350 devices
Jiangsu Qianjing Medical Equipment Co., Ltd.
21.7%323 devices
Wuxi Beien Surgery Device Co., Ltd.
18.7%278 devices
Baisheng Medical Co., Ltd.
7.2%107 devices
Shenzhen SINO-K Medical Technology Co., Ltd.
5.2%77 devices
About this profile

Explore comprehensive authorized representative profile for Prolinx GmbH through Pure Global AI's free EU medical device database. This organization represents 1489 medical devices registered with EUDAMED across 6 risk classes based in Germany.

This page provides detailed insights including recent registrations, risk class distribution (Class IIb: 722, Class I: 99, Class A: 4, Class IIa: 662, IVD devices for self-testing: 1, ...), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.