Identity
- Trade Name
- Clarius Scanner EC7 HD EUDAMED
- Device Name
- Clarius Ultrasound Scanner EUDAMED
- Model / Reference
- 99-13-00006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540205000946 EUDAMED
- Basic UDI-DI
- 7540205ClariusScannerD5 EUDAMED
- Direct Marketing DI
- 07540205000946 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Clarius Scanner EC7 HD by Clarius Mobile Health Corp. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540205ClariusScannerD5 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clarius Mobile Health Corp.
- EUDAMED SRN
- CA-MF-000037016
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 8f1e8678-f52e-4279-8f44-3cda4b274c79 61 fields · synced Jun 18, 2026