Identity
- Trade Name
- SonoTTTM aQuila I EUDAMED
- Model / Reference
- aQuila EUDAMED13858 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 40621140005946 EUDAMED
- Basic UDI-DI
- 4062114000587M6 EUDAMED
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
SonoTTTM aQuila I by em-tec GmbH — Class I — 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 | 4062114000587M6 | Class I | Active |
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Manufacturer
- Manufacturer
- em-tec GmbH
- EUDAMED SRN
- DE-MF-000008066
Sources (1)
- EUDAMED 07deefd8-cf6e-4094-b842-4969ae8deb53 61 fields · synced Jul 12, 2026