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InnoSight
EUDAMEDClass IIa (EU MDR)
Ref 5J.3AHTV.P02Model InnoSight/T3300/H1300
Identity
- Trade Name
- InnoSight EUDAMED
- Device Name
- Diagnostic Ultrasound System EUDAMED
- Model / Reference
- InnoSight/T3300/H1300 EUDAMED5J.3AHTV.P02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873000678 EUDAMED
- Basic UDI-DI
- 471987300VIVAPRO5J EUDAMED
- Direct Marketing DI
- 04719873000678 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
InnoSight 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 (1)
- EUDAMED 6069e03b-4a74-40c9-96ba-b41200de059f 61 fields · synced May 23, 2026