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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

4600 — IVDR Class A IVDR by BIOMES NGS GmbH

MD Atlas
BIOMES NGS GmbH

EUDAMED last updated this device on Mar 12, 2025

4600

4260582944600YH

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BIOMES NGS GmbH
UDI-DI code: 04260582940019
Reference / catalog number: 4600

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Manufacturer information

Organization name: BIOMES NGS GmbH
SRN: DE-MF-000042230
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

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: 04260582940019
Basic UDI-DI: 4260582944600YH
Reference / catalog number: 4600
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: SAMPLING.pro Kit provides a reliable and easy-to-use process for collecting, preserving, and preparing stool samples for subsequent laboratory analysis. It contains a tube with reagent for sample storage/transport and a swab for non-invasive sampling.
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

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.