EU → North America Device Access

medPhoton GmbH

AT-MF-000002648 · Austria · Salzburg

medPhoton GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb6

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include P01, P03, P04-1, P04-2.

European nomenclature codes declared: Z110312,Z11039009.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDPHOTON GMBH (AT) · FDA 3012631246
Devices in EUDAMED6
Country of registrationAustria

Device-level evidence

Devices with a numeric GTIN6
Found in the U.S. device database6
Share100.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMEDPHOTON GMBH

What it holds in Canada

Licences on record1
Currently active0
Class 3 devices1
First licensed2023-05-05

Licence types: Device Family (1).

Licensed under: IMAGINGRING M.

North American profile: Both markets. medPhoton GmbH is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
D4005200012supplemented2027-04-13

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