EU → North America Device Access

PHOTON 4 HEALTH B.V.

NL-MF-000048966 · Netherlands · Zwolle

PHOTON 4 HEALTH B.V. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa21

Most frequent device types declared: BASIC, CLINIC, GUTBRAIN BASIC, GUTBRAIN® PRO, PETS.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include H4H-1800PRO-01012024, H4H-4500PRO-01012024, H4H-BATHPRO-01012024, H4H-BOT9000-01012024, P4H-BODYS-01012024, P4H-RP-PETS-01012024.

European nomenclature codes declared: Z12040202, Z12159004, Z120606.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN21
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. PHOTON 4 HEALTH B.V. was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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