Identity
- Trade Name
- eM6C G2 EUDAMEDNA FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- eM6C G2 EUDAMED
- Model / Reference
- eM6C G2 EUDAMEDFDA UDIH48701ES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682120081 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00010GF EUDAMED
- Direct Marketing DI
- 00840682120081 EUDAMED
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- EMDN Code
- Z110402010402 TRANSCUTANEOUS ULTRASOUND ACTIVE MATRIX PROBES, MULTIDIMENSIONAL EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held 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
eM6C G2 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 | 8406821BUG00010GF | 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 b058d53a-9f3a-497d-8428-eb4ecba44892 61 fields · synced Oct 6, 2026
- FDA UDI f6b76faa-3e08-47ee-bc7d-83f031fea3ba 32 fields · synced May 30, 2026
- EUDAMED 03ced6ce-f1a0-4350-b262-77b030b3e0f0 61 fields · synced Jul 16, 2026