Identity
- Trade Name
- IC9B-RS EUDAMEDNA FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- IC9B-RS EUDAMEDFDA UDI
- Model / Reference
- 5835938 EUDAMEDH48062AK EUDAMEDIC9B-RS FDA UDI
- Description
- IC9B-RS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682147507 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00319HG EUDAMED
- Direct Marketing DI
- 00840682147507 EUDAMED
- 510(k) Number
- K201828 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX 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
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 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
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
Ic9b-Rs by GE Medical Systems CO. Ltd — 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 | 8406821BUG00319HG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED f2846b1c-0f3c-4ab2-91de-486e228cfa37 61 fields · synced Oct 6, 2026
- FDA UDI 31504169-c7f3-478b-84eb-7dd7ecaf0229 36 fields · synced May 30, 2026