BenQ
by Qisda Corporation 26 variants
Ref 9J.2SG21.908Model InnoSight/T3300/H1300
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 | Number471987300VIVAPRO5J 04719873009916 | Date10 May 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- Withdrawn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
- Diagnostic Ultrasound System
- Model / Reference
- InnoSight/T3300/H1300, 9J.2SG21.908
- Primary DI / UDI-DI
- 04719873009916
- Basic UDI-DI
- 471987300VIVAPRO5J
- Direct Marketing DI
- 04719873009916
- EMDN Code
- Z11040103 Portable ultrasound scanners
- Device Class
- Class IIa
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- TW-MF-000010709
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Qisda Corporation
Properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No