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One Lambda, Inc.

Manufacturer of medical devices registered in the European database in West Hills, United States.

Registration number (SRN)US-MF-000024901
RoleManufacturer
StatusActive
CountryUnited States
City91304 West Hills
AddressRoscoe Blvd. , 22801 91304 West Hills
Registered on2022-06-09

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryONE LAMBDA, INC (DE) · FDA 3013058950

Notified body certificates

CertificateStatusExpiryTypeBody
HX 2233216-1valid2030-10-28Quality management systemNB 0197

⚠️ 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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