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Organization name
UDI-DI code
Reference / catalog number

VOC-IMO-001 — IVDR Class A IVDR by VOC-Advanced Breath…

MD Atlas
VOC-Advanced Breath Diagnostics GmbH

EUDAMED last updated this device on Sep 10, 2025

VOC-IMO-001

4170000VOC-IMO-001FL

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VOC-Advanced Breath Diagnostics GmbH
UDI-DI code: 04170000250272
Reference / catalog number: VOC-IMO-001

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Manufacturer information

Organization name: VOC-Advanced Breath Diagnostics GmbH
SRN: DE-MF-000048809
Manufacturer status: Active

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: 04170000250272
Basic UDI-DI: 4170000VOC-IMO-001FL
Reference / catalog number: VOC-IMO-001
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Das Produkt dient der Sammlung, kurzfristigen physikalischen Konservierung und dem Transport ausgeatmeter Atemgasproben von Jugendlichen ab dem vollendeten 16. Lebensjahr und Erwachsenen mit Symptomen wie Obstipation, Blähungen und Bauchschmerzen einzeln oder im Rahmen eines Reizdarmsyndroms (überwiegend RDS-C) , die auf eine intestinale methanogene Überwucherung (IMO) hinweisen können. The product is intended for the collection, short-term physical preservation and transport of exhaled breath samples from adolescents aged 16 and over and adults with symptoms such as constipation, flatulence and abdominal pain either individually or as part of irritable bowel syndrome (predominantly IBS-C) which may indicate intestinal methanogenic overgrowth (IMO).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019099SAMPLES COLLECTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.