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Owlet Baby Care, Inc.

United States·US-MF-000026112

Last updated September 18, 2026

About

Monitor What Matters Most with the First-of-its-kind FDA-cleared smart baby monitor. Dream Sock® is the first-of-its-kind FDA-cleared smart baby monitor to offer Live Health Readings and Health Notifications. Learn more today.

From the manufacturer's own website. Source

Information

Country: United States
Address: 2940, West Maple Loop Dr., Lehi, United States
Website: www.owletcare.com/
LinkedIn: —
Facebook: facebook.com/OwletBabyMonitors
Email: [email protected]
Phone: +1 (844) 334-5330
PRRC Contact: Kristin Young
EUDAMED SRN: US-MF-000026112
FDA FEI Number: —
DUNS Number: 079422657

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
BabySat 3 Rx App	2.23.0	FDA UDI	Class II	Active
Dream Sock Monitoring System - Dusty Rose	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Wild Child (Duo)	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Bedtime Blue (Duo)	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Sweet Clementine (Duo)	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Dusty Rose (Duo)	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
BabySat 3 Rx Sensor	OSS 3.0-M1	FDA UDI	Class II	Active
BabySat 3 Rx Base Station	OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Blue Mist	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
BabySat Monitoring System	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Mint	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Bedtime Blue	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Mint (Duo)	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock App	3.0	FDA UDI	Class II	Active
Dream Sock Monitoring System - Wild Child	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock Monitoring System - Sweet Clementine	OSS 3.0-M1; OBL 3.0-M1	FDA UDI	Class II	Active
Dream Sock	PSR3NWDIN	EUDAMED	Class IIb	Active
BabySat 3	K222597	FDA 510(k)	Class II	Active
Dream Sock (Dusty Rose)	BMRHNN20IM; PSRHNN20IM	EUDAMED	Class IIb	Active
Dream Sock	PSR3NMWIN	EUDAMED	Class IIb	Active
Dream Sock (Mint)	BMRHNNMIM; PSRHNNMIM	EUDAMED	Class IIb	Active
Dream Sock	PSR3NWBIN	EUDAMED	Class IIb	Active
Dream Sock (Bedtime Blue)	BMRHNN67IM; PSRHNN67IM	EUDAMED	Class IIb	Active

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