immuClone (2) Anti-c IgM
by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED
Ref 0007317 EMDN W0103030202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 1191616-6 | Date9 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 1191616-6 Supplemented
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 9 Apr 2026
- Expires
- 27 Sep 2028
- Reason
- Other
Specification
- Device Name
- immuClone (2) Anti-c IgM and Galileo
- Model / Reference
- 0007317
- Primary DI / UDI-DI
- 10888234300427, 04042091000176
- Basic UDI-DI
- 88823405W0103030202D28JP, 40420910005E2X
- Direct Marketing DI
- 1088823430042704042091000176
- 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 b786015d-eefe-4b39-b169-e7793f1baf22
- EUDAMED 04042091000176|40420910005E2X