Pure Global AI
Manufacturer profile

Blue Sky Bio, LLC

EU EUDAMEDUnited States292 registered devices
VerifiedEUDAMED · official EU database
292
Total devices
2
Risk classes
2024
Earliest version
2024
Latest version
Regulatory footprint
Search Blue Sky Bio, LLC across other regulatory registries
ThailandColombiaSouth KoreaCanadaEcuadorSaudi Arabia
Recent products (latest 10)
Most recently updated devices in the database
CONDENSER
00810060223123
Class I
CONDENSER
00810060223093
Class I
CONDENSER
00810060223079
Class I
CONDENSER
00810060223109
Class I
CONDENSER
00810060223086
Class I
DRILL
00815131029543
Class IIa
DRILL
00815131029550
Class IIa
DRILL
00815131029536
Class IIa
DRILL
00815131029970
Class IIa
DRILL
00815131029291
Class IIa
Risk class distribution
Breakdown by risk classification
Class IIa18964.7% of total
Class I10335.3% of total
Top authorized representatives
Most common authorized representatives for this manufacturer
mdi Europa GmbH
100.0%292 devices
About this profile

Explore comprehensive manufacturer profile for Blue Sky Bio, LLC through Pure Global AI's free EU medical device database. This company manufactures 292 medical devices registered with EUDAMED across 2 risk classes based in United States.

This page provides detailed insights including recent registrations, risk class distribution (Class I: 103, Class IIa: 189), 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.