EU → North America Device Access

DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság

HU-MF-000004201 · Hungary · Gyöngyös

DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: Comfort Therapy Chair, Mobidock.

Among these devices, 21 are declared active.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 6300001, 723C1Z00, 723C3E01, 723C4B00, 723C4E01, 723C4P01.

European nomenclature codes declared: V08020101, V0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
Country of registrationHungary

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

Device-level evidence

Devices with a numeric GTIN22
Found in the U.S. device database10
Share45.5 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság was not found in either the U.S. or the Canadian register.

Other manufacturers in Hungary

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