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DIPLOMAT DENTAL s.r.o.

SK-MF-000002562 · Slovakia · Piešťany

DIPLOMAT DENTAL s.r.o. is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa39

Most frequent device types declared: D10L, MODEL PRO 800, MODEL PRO 700, XENOS, SIRIUS DS 1.

Among these devices, 38 are declared active.

Devices declared under this manufacturer

Showing 12 of 39 declared devices.

Catalogue references include DA 280, DA 370, DL 290, DL 320, MODEL PRO 500, MODEL PRO 700.

European nomenclature codes declared: Z12110101, Z12010701, Y180918.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED39
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 GTIN39
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. DIPLOMAT DENTAL s.r.o. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2025-MDR/QS-056issued2030-11-21

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