recomLine Chlamydia IgG
Ref 6172
recomLine Chlamydia IgG (6172) is a device classified as Class C (EU), IVD Annex II List B (EU) made by Mikrogen GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 42505711B2105WQ), active as of 7 Nov 2026.
Active
CE IVDR CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number42505711B2105WQ 04250571101194 | Date5 Nov 2026 | StatusActive |
| European Union | CE/IVDR | Number42505711B2105WQ 04250571101194 | Date5 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 42505711B2105WQ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Model / reference
- 6172
- Primary DI / UDI-DI
- 04250571101194
- Basic UDI-DI
- 42505711B2105WQ, B-04250571101194
- EMDN code
- W0105010199 Chlamydia reagents - other
- Device class
- Class CClass IVD Annex II List B
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000027747
Similar devices in this category
Other devices filed under CHLAMYDIA.
- D3 20-4310010 by DIAGNOSTIC HYBRIDS, INC.
- D3 DFA Chlamydiae Kit 01-040000 by DIAGNOSTIC HYBRIDS, INC.
- Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit R061T050B0C1 by Jiangsu Mole Bioscience Co., LTD.
- Chlamydia Antigen Rapid Test HCT024G by Hangzhou Immuno Biotech Co., Ltd
- iFlash-Chlamydia pn. IgM C88014M by SHENZHEN YHLO BIOTECH CO., LTD.
- RapidFor™ VMPO119 by Vitrosens Biotechnology Inc.
- LyoSens™ LYO48WS96 by Vitrosens Biotechnology Inc.
- Chlamydia Rapid Test ICH-502 by Hangzhou Alltest Biotech.Co.,Ltd.
- Aptima® KIT, BOX 2, RT, ACT, 100-T, AS, IVD 302941 by Hologic
- BD CTGCTV2 443979 by Becton, Dickinson and Company