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BenQ
EUDAMEDClass IIa (EU MDR)
Ref 9J.2SG01.005Model InnoSight/T3300/H1300Ref 9J.2SG21.907Ref 9J.2SG21.903Ref 9J.2SG01.003Ref 9J.2SG21.908Ref 9J.2SG01.006Ref 9J.2SG11.903Ref 9J.2SG03.202Ref 9J.2SG12.605
Identity
- Trade Name
- BenQ EUDAMED
- Device Name
- Diagnostic Ultrasound System EUDAMED
- Model / Reference
- InnoSight/T3300/H1300 EUDAMED9J.2SG01.005 EUDAMED9J.2SG21.907 EUDAMED9J.2SG21.903 EUDAMED9J.2SG01.003 EUDAMED9J.2SG21.908 EUDAMED9J.2SG01.006 EUDAMED9J.2SG11.903 EUDAMED9J.2SG03.202 EUDAMED9J.2SG12.605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873009848 EUDAMED04719873009855 EUDAMED04719873009367 EUDAMED04719873009343 EUDAMED04719873009916 EUDAMED04719873009909 EUDAMED04719873009299 EUDAMED04719873009305 EUDAMED04719873009329 EUDAMED
- Basic UDI-DI
- 471987300VIVAPRO5J EUDAMED
- Direct Marketing DI
- 04719873009848 EUDAMED04719873009855 EUDAMED04719873009367 EUDAMED04719873009343 EUDAMED04719873009916 EUDAMED04719873009909 EUDAMED04719873009299 EUDAMED04719873009305 EUDAMED04719873009329 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BenQ by Qisda Corporation — 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 | 471987300VIVAPRO5J | Class IIa | Active |
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Manufacturer
- Manufacturer
- Qisda Corporation
- EUDAMED SRN
- TW-MF-000010709
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (9)
- EUDAMED 412c1fc9-c9ec-4039-a50a-fb77ab5765e4 61 fields · synced Sep 18, 2026
- EUDAMED 0cd1382a-c69d-48e7-ad5b-99a93f6ee160 61 fields · synced May 11, 2026
- EUDAMED b001099a-d31d-493e-a845-e1692ab87ae1 61 fields · synced May 17, 2026
- EUDAMED 8744c0f5-cccc-46ab-aeff-af86a12ecac0 61 fields · synced May 17, 2026
- EUDAMED 3fb9193a-e41c-4751-bdac-899d21e6fa69 61 fields · synced May 17, 2026
- EUDAMED cd35e448-7f0c-4b15-9fde-0ec78228336c 61 fields · synced May 18, 2026
- EUDAMED 81b9df29-2360-4d4c-89ab-c91df104a59f 61 fields · synced May 18, 2026
- EUDAMED adae257a-960f-4cb2-b807-d78be9bc76b8 61 fields · synced May 18, 2026
- EUDAMED 5fe28749-920e-446a-8cd0-c78a30f402ff 61 fields · synced May 18, 2026