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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

13858 — Class I MDR by em-tec GmbH

MD Atlas
em-tec GmbH

EUDAMED last updated this device on Mar 5, 2026

13858

4062114000587M6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: em-tec GmbH
UDI-DI code: 40621140005946
Reference / catalog number: 13858

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Manufacturer information

Organization name: em-tec GmbH
SRN: DE-MF-000008066
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
Read these operating instructions carefully before use. Keep them in an easily accessible location for future reference. Please pay particular attention to the Intended Use and the Contraindications described in this document. Replacement copies of these operating instructions are available from the manufacturer.
CW273
Ensure the SonoTTTM aQuila I System is connected to the correct voltage prior to starting and using it.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 40621140005946
Basic UDI-DI: 4062114000587M6
Reference / catalog number: 13858
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: the SonoTTTM aQuila I, which is the medical device including the measurement electronics (i.e. the flow measurement boards), a touch display, the SonoTTTM aQuila I software, and a medical power supply
Additional information URL: https://www.psgdover.com/em-tec
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040111BLOOD FLOW METERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.