Identity
- Trade Name
- IC9-RS EUDAMEDNA FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- IC9-RS EUDAMEDFDA UDI
- Model / Reference
- IC9-RS EUDAMEDFDA UDIH48691PJ EUDAMED
- Description
- IC9-RS FDA UDI
Identifiers
- Catalog Number
- H48691PJ FDA UDI
- Primary DI / UDI-DI
- 00840682105026 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00444HL EUDAMED
- Direct Marketing DI
- 00840682105026 EUDAMED
- 510(k) Number
- K160162 FDA UDIK160184 FDA UDIK180374 FDA UDIK180535 FDA UDIK181783 FDA UDIK201828 FDA UDIK203114 FDA UDIK213642 FDA UDIK213689 FDA UDIK214039 FDA UDIK230346 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- EMDN Code
- Z1104020202 ENDOCAVITARY ULTRASOUND PROBES, MULTIDIMENSIONAL EUDAMED
- GMDN Term
- Rectal/vaginal ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI892.1570 FDA UDI
- Market of Registration
- Austria 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
Yes
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
Yes
FDA UDI
Ic9-Rs by GE Healthcare Austria GmbH & Co OG — 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 | 8406821BUG00444HL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Austria GmbH & Co OG
- EUDAMED SRN
- AT-MF-000001461
Sources (3)
- EUDAMED 35e963a9-cde2-4306-b540-1e128acc91ff 61 fields · synced Oct 6, 2026
- FDA UDI f3250edf-8090-49a5-b201-3131716f0cb4 36 fields · synced May 30, 2026
- EUDAMED 9f443062-01f5-4cf7-ae99-e5b8d44db7cf 61 fields · synced Jul 11, 2026