Interson USB Ultrasound Probe System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Interson USB Ultrasound Probe System EUDAMEDInterson FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- GP-C01 EUDAMEDUSB ultrasound probe, general purpose/abdominal FDA UDI
- Model / Reference
- Array probe EUDAMED99-7903-00 EUDAMEDGP-C01 FDA UDI
- Description
- USB ultrasound probe, general purpose/abdominal FDA UDI
Identifiers
- Catalog Number
- 99-7903 FDA UDI
- Primary DI / UDI-DI
- 00850921007004 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850921007004 EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Extracorporeal ultrasound imaging transducer, hand-held
Interson USB Ultrasound Probe System by Interson Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233734 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K163443 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00850921007004 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Interson Corporation
- EUDAMED SRN
- US-MF-000020801
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED da13bfaa-48ad-4aa6-8c03-9a181961bb9a 61 fields · synced Oct 6, 2026
- FDA UDI da42b15a-5185-4c37-bd22-7edef2f0e1f4 35 fields · synced May 30, 2026
- FDA 510(k) K233734 1 fields · synced May 18, 2026