Identity
- Trade Name
- Sleepiz One+ EUDAMEDFDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
- Device Name
- Sleepiz One+ EUDAMED
- Model / Reference
- 1.0 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649996477019 EUDAMEDFDA UDI
- Basic UDI-DI
- 764999647701SY EUDAMED
- Direct Marketing DI
- 07649996477019 EUDAMED
- 510(k) Number
- K223163 FDA UDI
- FDA Product Code
- BZQ FDA UDIDRT FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI870.2300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Sleepiz One+ by Sleepiz AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223163 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 764999647701SY | 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 (3)
- EUDAMED 3433482a-ca49-4a03-8cc2-e8747bdb0fa3 61 fields · synced Oct 6, 2026
- FDA UDI 032c4c44-ea92-40c3-af81-82a49aaf03b9 33 fields · synced May 30, 2026
- FDA 510(k) K223163 1 fields · synced May 18, 2026