Identity
- Trade Name
- Dream Sock EUDAMED
- Device Name
- Dream Sock EUDAMED
- Model / Reference
- PSR3NWDIN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810099091298 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 by Owlet Baby Care, Inc. — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Dream Sock
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081009909DreamSockHNNB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Owlet Baby Care, Inc.
- EUDAMED SRN
- US-MF-000026112
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 20522fc3-4448-4f19-90b0-7524167336b0 61 fields · synced Oct 7, 2026