Identity
- Trade Name
- WatchPAT™ Central Plus Sensor EUDAMEDCentral Plus Sensor FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Watch-PAT300 EUDAMEDCentral Plus Sensor for WatchPAT300 FDA UDI
- Model / Reference
- AC3000115 EUDAMEDCentral Plus Sensor FDA UDI
- Description
- Central Plus Sensor for WatchPAT300 FDA UDI
Identifiers
- Catalog Number
- AC3000115 FDA UDI
- Primary DI / UDI-DI
- 07290109223193 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010922AC21107M9 EUDAMED
- 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
- Italy 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™ Central Plus Sensor 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 (2)
- EUDAMED 2362bab2-e32d-4cb9-aa47-f97b1e05c187 61 fields · synced Jul 10, 2026
- FDA UDI d45b6ea4-cf87-4a91-adc7-bc968984fefc 37 fields · synced May 30, 2026