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

Rapid H.pylori Antigen Test Card — IVDD — General IVDD

MD Atlas
MP Biomedicals Germany GmbH

EUDAMED last updated this device on May 20, 2026

Rapid H.pylori Antigen Test Card

B-04260163315649

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: MP Biomedicals Germany GmbH
UDI-DI code: 04260163315649
Reference / catalog number: 07HPY025ST

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: MP Biomedicals Germany GmbH
SRN: DE-MF-000020991
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Rapid H.pylori Antigen Test Card
UDI-DI code: 04260163315649
Basic UDI-DI: B-04260163315649
Reference / catalog number: 07HPY025ST
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: INTENDED USE Rapid H. pylori Antigen Test Card is an in-vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H. pylori in peptic ulcer patients. The test is intended for healthcare professionals use.
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

MP Rapid Drugs of Abuse Test StripB-04260163315915On the market 2-MET Plasma ELISA Fast TrackB-07LE8300R7On the market Diagnostic Kit for C-reactive ProteinB-04260163315724On the market Diagnostic Kit for Cardiac Troponin IB-04260163315731On the market Diagnostic Kit for CK-MBB-04260163315717On 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.