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Cables
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1248Model 5004-X, 5005-X, 5014-X series
by S.L.P. Ltd.
Identity
- Trade Name
- Sleepsense FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Device Name
- Cables EUDAMED
- Model / Reference
- 5004-X, 5005-X, 5014-X series EUDAMED1248 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290012186684 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290008986CA002TU 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
- Belgium 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
Yes
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
Cables 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 | 7290008986CA002TU | 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 (2)
- EUDAMED d6a90491-a0e8-4a3e-a14e-70a6a923998f 61 fields · synced Jul 18, 2026
- FDA UDI 75eaf697-9181-4010-be5e-8984ebf484b8 33 fields · synced May 30, 2026