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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

Geratherm® chlamydia check — IVDD — Self-testing IVDD

MD Atlas
Geratherm Medical GERMANY GmbH

EUDAMED last updated this device on Jun 12, 2023

Geratherm® chlamydia check

B-4018674GTCST01UUEW

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Geratherm Medical GERMANY GmbH
UDI-DI code: D-4018674GTCST01UUEW
Reference / catalog number: 9750000660

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Manufacturer information

Organization name: Geratherm Medical GERMANY GmbH
SRN: DE-MF-000007307
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
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: Geratherm® chlamydia check
UDI-DI code: D-4018674GTCST01UUEW
Basic UDI-DI: B-4018674GTCST01UUEW
Reference / catalog number: 9750000660
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: The Geratherm® chlamydia check is a rapid antigen test for direct qualitative detection of Chlamydia trachomatis antigen in vaginal swab specimens. Chlamydia trachomatis, one of the most common sexually transmitted pathogens is a major cause of cervicitis, urethritis, endometritis and pelvic inflammatory disease in women. Untreated Chlamydia trachomatis infection can result in infertility, salpingitis and ectopic pregnancy. If transmitted to infants during birth, Chlamydia can cause conjunctivitis and pneumonia.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010107CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Manufacturing date
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Software identification

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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.