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Pragmatech AI Solutions

Manufacturer of medical devices registered in the European database in Oviedo, Spain.

Registration number (SRN)ES-MF-000039516
Short namePragmatech
RoleManufacturer
StatusActive
CountrySpain
City33001 Oviedo
AddressCalle Manuel García Conde, 3 33001 Oviedo
Registered on2024-01-11

United States market access

FDA establishment register Not found in the U.S. FDA register

⚠️ Not found is not the same as not registered. The two registers share no common identifier; the comparison is made on company names. This manufacturer may reach the United States through a distributor, or be registered under a name we could not match. State of the FDA register on 2026-08-20.

Notified body certificates

CertificateStatusExpiryTypeBody
2025 CR 0055valid2030-07-02Quality management systemNB 0318

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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