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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

360 500 — Class I MDR by mbnet Engineering GmbH

MD Atlas
mbnet Engineering GmbH

EUDAMED last updated this device on Apr 10, 2025

360 500

426071872ergovac5B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: mbnet Engineering GmbH
UDI-DI code: 04260718720027
Reference / catalog number: 360 500

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Manufacturer information

Organization name: mbnet Engineering GmbH
SRN: DE-MF-000007410
Manufacturer status: Active

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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.

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: 04260718720027
Basic UDI-DI: 426071872ergovac5B
Reference / catalog number: 360 500
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 ergo vac is an ECG suction device for transmitting heart potentials during resting and stress ECGs and sending the data to the ECG device.The built-in control panel allows for easy operation and efficient configuration of the device. The device is suitable for use inside hospitals, cardiology centers, outpatient clinics and medical practices. The devise may only be used by qualified doctors or trained and medical staff
Additional information URL: https://www.mbnet.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

C020599CARDIAC DIAGNOSTIC DEVICES - OTHER

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

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