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ThermoCan Interface cable Pediatric (Thermocouple) / Safety DIN Connectors
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1475PModel 147X, 147XX-X, 147XX-X-X, 148X seriesRef NA-1475P
by S.L.P. Ltd.
Identity
- Trade Name
- ThermoCan Interface cable Pediatric (Thermocouple) / Safety DIN Connectors EUDAMEDSleepsense FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Device Name
- ThermoCan Interface Cables EUDAMED
- Model / Reference
- 147X, 147XX-X, 147XX-X-X, 148X series EUDAMED1475P EUDAMEDFDA UDINA-1475P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290013818096 EUDAMEDFDA UDI07290016716597 EUDAMED
- Basic UDI-DI
- 7290013819TH001VD 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
ThermoCan Interface cable Pediatric (Thermocouple) / Safety DIN Connectors by S.L.P. Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7290013819TH001VD | 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 76094602-b250-415f-93ca-46edadf4e433 61 fields · synced Jul 30, 2026
- EUDAMED c0658f58-4a5f-415b-8909-ab8448f773a6 61 fields · synced May 18, 2026
- FDA UDI 6f29168c-8476-4e5e-b427-39f6955b8774 33 fields · synced May 30, 2026