EU → North America Device Access

Auguste Cryogenics Slovakia s.r.o.

SK-MF-000026173 · Slovakia · Košice

Auguste Cryogenics Slovakia s.r.o. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: AC Medical Freezer.

Devices declared under this manufacturer

Catalogue references include AC BIO 430, AC BIO 430X, AC BIO 860, AC IVF 430, AC SYS 480.

European nomenclature codes declared: Z121702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationSlovakia

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Auguste Cryogenics Slovakia s.r.o. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2026-MDR/QS-012issued2031-02-09

Other manufacturers in Slovakia

All Slovakia manufacturers →