Identity
- Trade Name
- IC5-9-D EUDAMEDNA FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- IC5-9-D EUDAMED
- Model / Reference
- 5194434 EUDAMEDH40442LK EUDAMEDIC5-9-D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682108584 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00235H9 EUDAMED
- Direct Marketing DI
- 00840682108584 EUDAMED
- 510(k) Number
- K160182 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDIIYN FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Rectal/vaginal ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.1550 FDA UDI
- Market of Registration
- France 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
Ic5-9-D by GE Healthcare Japan 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 | 8406821BUG00235H9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Japan Corporation
- EUDAMED SRN
- JP-MF-000009291
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 5debc948-0e69-4b77-aeaa-1fb599f21e75 61 fields · synced Jun 18, 2026
- FDA UDI 6bd44e95-2fa9-48f8-9a08-f31e4bfe0e28 34 fields · synced May 30, 2026