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Owlet Baby Care, Inc.

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

Registration number (SRN)US-MF-000026112
Short nameOwlet
RoleManufacturer
StatusActive
CountryUnited States
City84048 Lehi
AddressWest Maple Loop Dr., 2940 84048 Lehi
Registered on2022-07-15

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryOWLET BABY CARE (US) · FDA 3012977166

Notified body certificates

CertificateStatusExpiryTypeBody
US25/00000423valid2029-04-07Quality management systemNB 1639

⚠️ 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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