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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

HELICOBACTER PYLORI AB RAPID TEST… — IVDR Class B IVDR

MD Atlas
VitroBioChem SRL

EUDAMED last updated this device on May 25, 2026

HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)

5944759080VTHPB25SPROB6HC

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitroBioChem SRL
UDI-DI code: 05944759080010
Reference / catalog number: VT-HPBSP-25

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View device family (Basic UDI)

Manufacturer information

Organization name: VitroBioChem SRL
SRN: RO-MF-000010877
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	May 28, 2026	Dec 31, 2030

Device identification

Trade name: HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)
UDI-DI code: 05944759080010
Basic UDI-DI: 5944759080VTHPB25SPROB6HC
Reference / catalog number: VT-HPBSP-25
Issuing entity: GS1

Classification

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

Device details

Quantity: 25
Additional product description: HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944759080010

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105090102H. PYLORI - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.