uPAT™ Probe
by Itamar Medical Ltd. 3 variants
Ref AC2111303
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number729010922AC21107M9 07290109223483 | Date22 Jun 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Watch-PAT300
- Model / Reference
- AC2111303
- Primary DI / UDI-DI
- 07290109223483
- Basic UDI-DI
- 729010922AC21107M9
- EMDN Code
- Z12100585 Polysomnography instruments - consumables
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IL-MF-000012046
- Authorised representative
- Arazy Group GmbH DE-AR-000007685
Other devices from Itamar Medical Ltd
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No