C83B Transducer
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- InnoSight EUDAMEDC83B Transducer FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Diagnostic Ultrasound System EUDAMEDC83B-Apollo Transducer FDA UDI
- Model / Reference
- InnoSight/T3300/H1300 EUDAMED9J.2SG23.111 EUDAMED989606700441 FDA UDI
- Description
- C83B-Apollo Transducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873009183 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987300VIVAPRO5J EUDAMED
- Direct Marketing DI
- 04719873009183 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
Single Use
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Extracorporeal ultrasound imaging transducer, hand-held
C83B Transducer by Qisda Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qisda Corporation
Sources (2)
- FDA UDI 6b878e8c-b1da-499c-85fd-a2d1a23277eb 33 fields · synced Aug 3, 2026
- EUDAMED bce3aa31-0d5b-42dd-b902-418663aac106 61 fields · synced Aug 3, 2026