Identity
- Trade Name
- Clarius Scanner L7 HD3 EUDAMEDClarius Ultrasound Scanner FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- Clarius Ultrasound Scanner EUDAMEDPortable Ultrasound Scanner FDA UDI
- Model / Reference
- 99-13-00020 EUDAMEDClarius Scanner L7 HD3 FDA UDI
- Description
- Portable Ultrasound Scanner FDA UDI
Identifiers
- Catalog Number
- 99-13-00020, 99-02-00077 FDA UDI
- Primary DI / UDI-DI
- 07540205001196 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540205ClariusScannerD5 EUDAMED
- Direct Marketing DI
- 07540205001196 EUDAMED
- 510(k) Number
- K213436 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Hand-held ultrasound imaging system, body-surface 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Clarius Scanner L7 HD3 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 2ffbe530-67bd-479a-a988-2c4358db8593 61 fields · synced Jul 11, 2026
- FDA UDI f4fea4ae-0de4-4817-bfcb-96863abed9db 35 fields · synced May 30, 2026