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InnoSight
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5J.3AHLL.P01Model InnoSight/T3300/H1300
Identity
- Trade Name
- InnoSight EUDAMEDL12-4 Transducer FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Diagnostic Ultrasound System EUDAMED
- Model / Reference
- InnoSight/T3300/H1300 EUDAMED5J.3AHLL.P01 EUDAMED989605463401 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873000043 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987300VIVAPRO5J EUDAMED
- Direct Marketing DI
- 04719873000043 EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
InnoSight by Qisda Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987300VIVAPRO5J | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Qisda Corporation
- EUDAMED SRN
- TW-MF-000010709
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 2ce18572-f1cc-4d77-94b0-0cb14751e373 61 fields · synced Jul 20, 2026
- FDA UDI b640ac89-36a3-4107-b070-fbc86dba25ef 32 fields · synced May 30, 2026