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Piezo Respiratory Effort Sensor Kit - Double Buckle for Alice 3
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1397-KitModel 13XX, 612XX series
by S.L.P. Ltd.
Identity
- Trade Name
- Piezo Respiratory Effort Sensor Kit - Double Buckle for Alice 3 EUDAMEDSleepsense FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Device Name
- Effort Sensors EUDAMED
- Model / Reference
- 13XX, 612XX series EUDAMED1397-Kit EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290012144455 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290008986EF001VK 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
Piezo Respiratory Effort Sensor Kit - Double Buckle for Alice 3 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 | 7290008986EF001VK | 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 286f15b5-cda2-429c-95c2-ec6fae5c876a 61 fields · synced Jul 9, 2026
- FDA UDI 67aa2eb3-6128-4088-bf3c-8bbbb800cd94 32 fields · synced May 30, 2026