immuClone (1) Anti-C IgM
by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED
Ref 0007206
EMDN W0103030202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 1191616-3 | Date14 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austriasince 20 Jan 2004
- Belgiumsince 20 Jan 2004
- Bulgariasince 20 Jan 2004
- Croatiasince 20 Jan 2004
- Cyprussince 20 Jan 2004
- Czechiasince 20 Jan 2004
- Denmarksince 20 Jan 2004
- Estoniasince 20 Jan 2004
- Finlandsince 20 Jan 2004
- Francesince 20 Jan 2004
- Germanysince 20 Jan 2004
- Greecesince 20 Jan 2004
- Hungarysince 20 Jan 2004
- Icelandsince 20 Jan 2004
- Irelandsince 20 Jan 2004
- Italysince 20 Jan 2004
- Latviasince 20 Jan 2004
- Liechtensteinsince 20 Jan 2004
- Lithuaniasince 20 Jan 2004
- Luxembourgsince 20 Jan 2004
- Maltasince 20 Jan 2004
- Netherlandssince 20 Jan 2004
- Northern Irelandsince 20 Jan 2004
- Norwaysince 20 Jan 2004
- Polandsince 20 Jan 2004
- Portugalsince 20 Jan 2004
- Romaniasince 20 Jan 2004
- Slovakiasince 20 Jan 2004
- Sloveniasince 20 Jan 2004
- Spainsince 20 Jan 2004
- Swedensince 20 Jan 2004
- Türkiyesince 20 Jan 2004
Certificates
- IX 1191616-3 Supplemented
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 14 Apr 2026
- Expires
- 27 Sep 2028
- Reason
- Other
Specification
- Device Name
- immuClone (1) Anti-C IgM and Galileo
- Model / Reference
- 0007206
- Primary DI / UDI-DI
- 10888234300298, 04042091000107
- Basic UDI-DI
- 88823405W0103030202D22JB, 40420910000E2G
- Direct Marketing DI
- 1088823430029804042091000107
- EMDN Code
- W0103030202 Rhesus phenotypes
- Device Class
- Class D
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006494
Other devices from IMMUCOR Medizinische Diagnostik GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED c993b15a-fdeb-497a-9e90-05d493c21a11
- EUDAMED 04042091000107|40420910000E2G