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Sleepiz One+ Connect
EUDAMEDClass IIa (EU MDR)
Ref 40Ref 30Ref 09Ref 05Model 3.0
by Sleepiz AG
Identity
- Trade Name
- Sleepiz One+ Connect EUDAMEDSleepiz One+ EUDAMED
- Device Name
- Sleepiz One+ Connect EUDAMEDSleepiz One+ EUDAMED
- Model / Reference
- 40 EUDAMED30 EUDAMED09 EUDAMED3.0 EUDAMED05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649996477408 EUDAMED07649996477309 EUDAMED07649996477095 EUDAMED07649996477057 EUDAMED
- Basic UDI-DI
- 7649996477PP02QE EUDAMED7649996477WAXG EUDAMED7649996477NGCS012U EUDAMED764999647703T4 EUDAMED
- Direct Marketing DI
- 07649996477408 EUDAMED07649996477309 EUDAMED07649996477095 EUDAMED07649996477057 EUDAMED
- EMDN Code
- Z129011 MULTI-DISCIPLINARY TELEMETRY SYSTEMS EUDAMEDZ12030282 VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMEDZ12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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+ Connect by Sleepiz AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 7649996477PP02QE | 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 (4)
- EUDAMED fe64db56-2f87-4671-99d1-d8436f1f111f 61 fields · synced Oct 6, 2026
- EUDAMED 2394a891-0235-4113-ab59-33501a7c2b2d 61 fields · synced May 17, 2026
- EUDAMED 32fe90e9-1b13-459c-b4df-d0a9ef0d43f1 61 fields · synced May 18, 2026
- EUDAMED 847963c0-f721-4205-a842-8ede3c1f35c3 61 fields · synced May 18, 2026