Identity
- Trade Name
- E8Cs-RS EUDAMEDNA FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- E8Cs-RS EUDAMED
- Model / Reference
- 5641682 EUDAMEDH48062AF EUDAMEDE8Cs-RS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682116831 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00317HC EUDAMED
- Direct Marketing DI
- 00840682116831 EUDAMED
- 510(k) Number
- K160277 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO 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
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 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
E8Cs-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 | 8406821BUG00317HC | 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 1312e074-8192-4638-8919-e98147a803bc 61 fields · synced Jul 9, 2026
- FDA UDI d8ca97bc-ad4e-444e-ab76-c111624c14e6 34 fields · synced May 30, 2026