Identity
- Trade Name
- WatchPAT™300 EUDAMEDWatchPAT™400 EUDAMEDWatch-PAT300 FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Watch-PAT300 EUDAMEDWatchPAT400 EUDAMEDWatch-PAT300 Device FDA UDI
- Model / Reference
- AS2110700 EUDAMEDAS2110900 EUDAMEDWatch-PAT300 FDA UDI
- Description
- Watch-PAT300 Device FDA UDI
Identifiers
- Catalog Number
- AS2110700 FDA UDI
- Primary DI / UDI-DI
- 07290109222417 EUDAMEDFDA UDI07290109223568 EUDAMED
- Basic UDI-DI
- 729010922AC21107M9 EUDAMED729010922AC21109MD EUDAMED
- 510(k) Number
- K180775 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Netherlands EUDAMEDBelgium 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
WatchPAT™300 by Itamar Medical Ltd — Class IIa — 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 | 729010922AC21107M9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Itamar Medical Ltd.
- EUDAMED SRN
- IL-MF-000012046
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (3)
- EUDAMED bad4456e-fb7e-4acf-8f31-776305d95c8d 61 fields · synced Jul 18, 2026
- FDA UDI 3abd479d-6d99-44ad-ad67-15472d86bd6d 37 fields · synced May 30, 2026
- EUDAMED 1614e609-47c2-4559-ab57-8a26391a014c 61 fields · synced Jul 18, 2026