Identity
- Trade Name
- Clarius App - iOS EUDAMEDClarius Ultrasound Scanner FDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- Clarius Ultrasound Scanner EUDAMED
- Model / Reference
- 12-01-00003 EUDAMEDApp - iOS FDA UDI
Identifiers
- Catalog Number
- 12-01-00003 FDA UDI
- Primary DI / UDI-DI
- 07540205000397 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540205ClariusScannerD5 EUDAMED
- Direct Marketing DI
- 07540205000397 EUDAMED
- 510(k) Number
- K163138 FDA UDIK172385 FDA UDIK180799 FDA UDIK192107 FDA UDIK213436 FDA UDIK222406 FDA UDIK232257 FDA UDIK232704 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040182 ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasound imaging system application software 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
- Ireland 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Clarius App - iOS by Clarius Mobile Health Corp. — 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 | 7540205ClariusScannerD5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Clarius Mobile Health Corp.
- EUDAMED SRN
- CA-MF-000037016
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fb6ac193-377d-4962-996c-6a46d36dede4 61 fields · synced Jun 18, 2026
- FDA UDI 1941c4e7-99ff-4134-b860-df29fc318f84 34 fields · synced May 30, 2026