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Thermistor Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref NA-1450-KITModel 14XX, 610XX, 613XX series
by S.L.P. Ltd.
Identity
- Trade Name
- Thermistor Kit EUDAMEDNatus FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Device Name
- Flow Sensors EUDAMED
- Model / Reference
- 14XX, 610XX, 613XX series EUDAMEDNA-1450-KIT EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290013818799 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290013385FL001QK EUDAMED
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Polysomnography analyser FDA UDI
Classification
- Device Class
- Class I EUDAMED
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Thermistor Kit 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 | 7290013385FL001QK | 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 e72c5d82-300d-45bb-8c15-8b960cdca45e 61 fields · synced Jul 10, 2026
- FDA UDI fd01468a-1a9f-4dbc-b5c9-c9af17106b4e 32 fields · synced May 30, 2026