EU → North America Device Access

Oy Apotti Ab

FI-MF-000007544 · Finland · Helsinki

Oy Apotti Ab is registered in the European database on medical devices as a manufacturer, with 63 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa63

Among these devices, 63 are declared active.

Devices declared under this manufacturer

Showing 12 of 63 declared devices.

Catalogue references include OLL0001018 CHA2DS2-VASc, OLL0001033 Danish Prosthatic Symptom Score, OLL0001054 AVO YHDISTELMÄEHKÄISY JA MIGREENIDIAGNOOSI, OLL0001072 ANE Suositus Postoperatiivisen pahoinvoinnin ja oksentelun , OLL0001087 Tobramysiini pitoisuus yli 0,4, OLL0001094 Brief psychiateric rating scale + 3.

European nomenclature codes declared: V92.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED63
Country of registrationFinland

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

Device-level evidence

Devices with a numeric GTIN1
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. Oy Apotti Ab was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
FI25/00000062issued2028-10-23

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