Identity
- Trade Name
- RM7C EUDAMEDNA FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- RM7C EUDAMED
- Model / Reference
- RM7C EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682143271 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00107GX EUDAMED
- Direct Marketing DI
- 00840682143271 EUDAMED
- 510(k) Number
- K181985 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO 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
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 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
Rm7c 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 | 8406821BUG00107GX | 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 49567767-0ce0-4f7c-b1ed-f2eb4bd6759c 61 fields · synced Oct 6, 2026
- FDA UDI f4369fd6-643b-49e3-8ca4-b1c162fca89e 35 fields · synced May 30, 2026
- EUDAMED ce9694c0-f151-4ce7-9d05-8eb756d43d40 61 fields · synced Jul 14, 2026