Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

200.070 — IVDD — General IVDD by preOx.RS GmbH

MD Atlas
preOx.RS GmbH

EUDAMED last updated this device on Apr 29, 2025

200.070

B-04260702150137

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: 04260702150137
Reference / catalog number: 200.070

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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.

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: 04260702150137
Basic UDI-DI: B-04260702150137
Reference / catalog number: 200.070
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