Identity
- Trade Name
- WatchPAT™ Central Plus Sensor EUDAMED
- Device Name
- Watch-PAT300 EUDAMED
- Model / Reference
- AC3000113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290109223506 EUDAMED
- Basic UDI-DI
- 729010922AC21107M9 EUDAMED
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
WatchPAT™ Central Plus Sensor by Itamar Medical Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729010922AC21107M9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Itamar Medical Ltd.
- EUDAMED SRN
- IL-MF-000012046
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (1)
- EUDAMED 08b4addf-ba97-4586-bc69-e6e68c69c5c0 61 fields · synced Jun 20, 2026