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Piezo Snore Sensor for Alice 6
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1267Model 12XX seriesRef 1267-LO
by S.L.P. Ltd.
Identity
- Trade Name
- Piezo Snore Sensor for Alice 6 EUDAMEDSleepsense FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Device Name
- Snore Sensors EUDAMED
- Model / Reference
- 12XX series EUDAMED1267 EUDAMEDFDA UDI1267-LO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290013817921 EUDAMEDFDA UDI07290016714241 EUDAMED
- Basic UDI-DI
- 7290012186SN001TY EUDAMED
- 510(k) Number
- K042253 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Polysomnography analyser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Piezo Snore Sensor for Alice 6 by S.L.P. Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290012186SN001TY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.L.P. Ltd.
- EUDAMED SRN
- IL-MF-000016600
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (3)
- EUDAMED 0e6821a6-0c23-4901-9f98-ad30507a9dff 61 fields · synced Sep 18, 2026
- EUDAMED 5d996ebc-bfcb-407f-b28b-19d34b948971 61 fields · synced May 19, 2026
- FDA UDI 4a0b00fb-65aa-444f-b53a-2660f751e3ca 33 fields · synced May 29, 2026