Identity
- Trade Name
- SOMNOscreen HD EEG32 with Camera FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- NGDV741U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413410699 FDA UDI
- 510(k) Number
- K071556 FDA UDI
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polysomnograph
SOMNOscreen HD EEG32 with Camera by Somnomedics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071556 also covers:
- 1 channel ECG sensor including body position and disposable electrodes — Somnomedics GmbH
- 1-channel ECG Electrode — Somnomedics GmbH
- Digital PSG Head Box for SOMNO HD — Somnomedics GmbH
- Miniaturized Pneumotachograph Set — Somnomedics GmbH
- SLP Thermistor LOW COST — Somnomedics GmbH
- SOMNO HD / ECO accessory — Somnomedics GmbH
- SOMNOscreen ECO EEG 32 — Somnomedics GmbH
- SOMNOscreen HD PSG — Somnomedics GmbH
- SOMNOscreen HD PSG Tele — Somnomedics GmbH
- SOMNOscreen eco — Somnomedics GmbH
- Set for wireless PLM measurement — Somnomedics GmbH
- Simplified Sleep Stage Evaluation — Somnomedics GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Somnomedics GmbH
Sources (1)
- FDA UDI 00b3066d-17ba-4021-87ae-9471fabfdc34 33 fields · synced May 30, 2026