Eu Ivdd
Eu Ivd Self Testing
On The Market
🇩🇪 Germany
Geratherm® chlamydia check
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-4018674GTCST01UUEW
- Basic UDI-DI Code
- B-4018674GTCST01UUEW
- Reference
- 9750000660
- Device Types
-
Single use Sterile
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Geratherm Medical GERMANY GmbH
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010107 | CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 1448710-1 | TÜV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇩🇪 Germany
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