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NewWaterMeaning s.r.o.

CZ-MF-000006576 · Czechia · Praha 8

NewWaterMeaning s.r.o. is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb15

Most frequent device types declared: DebriEcaSan Alfa 115ml, DebriEcaSan Alfa 3 L canister, DebriEcaSan Alfa 5 L canister, DebriEcaSan Alfa 500ml push pull, DebriEcaSan aquagel 250g.

Catalogue references include 0227, 0234, 0272, 0326, 0715, 0722.

European nomenclature codes declared: M04041503.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
Country of registrationCzechia

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

Device-level evidence

Devices with a numeric GTIN15
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. NewWaterMeaning s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

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