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Cosmonde, a.s.

CZ-MF-000029535 · Czechia · Brno

Cosmonde, a.s. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb9

Devices declared under this manufacturer

Catalogue references include CM007A-BL, Z1000, Z1001, Z1002, Z1003, Z1004.

European nomenclature codes declared: M9002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. Cosmonde, a.s. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2025-MDR/QS-030/Aissued2030-05-13
2025-MDR/QS-029/Aissued2030-05-13

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