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Dream Sock (Bedtime Blue)
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref BMRHNN67IM; PSRHNN67IM510(k) DEN220091
Identity
- Trade Name
- Dream Sock (Bedtime Blue) EUDAMED
- Device Name
- Dream Sock EUDAMED
- Model / Reference
- BMRHNN67IM; PSRHNN67IM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810099091090 EUDAMED
- Basic UDI-DI
- 081009909DreamSockHNNB EUDAMED
- EMDN Code
- Z12030280,Z12030292 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dream Sock (Bedtime Blue) by Owlet Baby Care, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Manufacturer's product page: Dream Sock
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN220091 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 081009909DreamSockHNNB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Owlet Baby Care, Inc.
- EUDAMED SRN
- US-MF-000026112
- FDA Applicant
- Owlet Babycare, Inc.
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 60918fb8-32b7-4a77-8c46-6f33689ac5b4 85 fields · synced Jun 19, 2026
- FDA 510(k) DEN220091 1 fields · synced May 18, 2026