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Sleepiz One+
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 04Model 2.5510(k) K251364
by Sleepiz AG
Identity
- Trade Name
- Sleepiz One+ EUDAMED
- Device Name
- Sleepiz One+ EUDAMED
- Model / Reference
- 2.5 EUDAMED04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649996477040 EUDAMED
- Basic UDI-DI
- 7649996477025L4 EUDAMED
- Direct Marketing DI
- 07649996477040 EUDAMED
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sleepiz One+ by Sleepiz AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K251364 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7649996477025L4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sleepiz AG
- EUDAMED SRN
- CH-MF-000011783
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (2)
- EUDAMED 97412c4d-120f-4436-b515-cf9005c61a5b 85 fields · synced Jun 19, 2026
- FDA 510(k) K251364 1 fields · synced May 18, 2026