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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

200.101 — IVDD — General IVDD by preOx.RS GmbH

MD Atlas
preOx.RS GmbH

EUDAMED last updated this device on Apr 29, 2025

200.101

B-04260702150151

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: preOx.RS GmbH
UDI-DI code: 04260702150151
Reference / catalog number: 200.101

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Manufacturer information

Organization name: preOx.RS GmbH
SRN: DE-MF-000005017
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW999
Bei Farbumschlag in Richtung Rosa dieses Röhrchen N I C H T verwenden.

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: 04260702150151
Basic UDI-DI: B-04260702150151
Reference / catalog number: 200.101
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: In-vitro Test zum schnellen Nachweis einer Helicobacter pylori Infektion im Magen basierend auf der Aktivität des Enzyms Urease in einer Biopsie
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105090102H. PYLORI - RT & POC

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

200.103B-04260702150175On the market preOx - HUTB-04260702150168On the market 200.050B-04260702150113On the market 200.104B-04260702150182On the market 200.060B-04260702150120On the market

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.