Pure Global AI
Authorized representative profile

SUNGO Europe B.V.

EU EUDAMEDNetherlands14569 represented devicesSRN NL-AR-000000247
VerifiedEUDAMED · official EU database
14,569
Total devices
7
Risk classes
2021
Earliest version
2025
Latest version
Regulatory footprint
Search SUNGO Europe B.V. across other regulatory registries
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Recent products (latest 10)
Most recently updated devices in the database
Diaper/Pants Diaper/Underwear
06949648108157
Class I
Gingival Barrier
06970016620339
Class I
Dental Foil
06975527187722
Class I
Urine Drainage Bag
06945934603016
Class I
Underpad
06949648108225
Class I
Dental Impression Material
06970016620285
Class I
Dental Foil
06975527187753
Class I
Dental Foil
06975527187715
Class I
Dental Foil
06975527187739
Class I
Spectacle Frames
06977987930009
Class I
Risk class distribution
Breakdown by risk classification
Class I1089274.8% of total
Class IIa13089.0% of total
Class A11347.8% of total
IVD General8085.5% of total
Class IIb4152.8% of total
IVD devices for self-testing100.1% of total
IVD Annex II List B20.0% of total
Top manufacturers
Most common manufacturers represented by this AR
Chengdu Sani Medical Equipment Co.,Ltd.
6.8%996 devices
WILSON (Shanghai) Medical Device Co., Ltd.
6.0%871 devices
Foshan Mason Tech Co., Ltd.
4.3%632 devices
Zhejiang Yo Medical Technology Co., Ltd
3.7%532 devices
Zhangjiagang Bestran Technology Co.,Ltd
3.4%499 devices
About this profile

Explore comprehensive authorized representative profile for SUNGO Europe B.V. through Pure Global AI's free EU medical device database. This organization represents 14569 medical devices registered with EUDAMED across 7 risk classes based in Netherlands.

This page provides detailed insights including recent registrations, risk class distribution (IVD General: 808, Class I: 10892, Class A: 1134, Class IIa: 1308, Class IIb: 415, ...), 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.