immuClone (1) Anti-K IgM
by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED
Ref 0008016, 0008026 EMDN W0103030501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 1191616-12 | Date9 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 1191616-12 Supplemented
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 9 Apr 2026
- Expires
- 21 Nov 2028
- Reason
- Other
Specification
- Device Name
- immuClone (1) Anti-K IgM and Galileo
- Model / Reference
- 0008016, 0008026
- Primary DI / UDI-DI
- 10888234300625, 10888234300632, 04042091000299, 04042091000305
- Basic UDI-DI
- 88823405W0103030501D26KK, 40420910001M33
- Direct Marketing DI
- 10888234300625108882343006320404209100029904042091000305
- EMDN Code
- W0103030501 Other antigen typing reagents
- 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 (4)
- EUDAMED c7c5d81c-f19e-4318-b037-395d45420361
- EUDAMED 10888234300632|88823405W0103030501D26KK
- EUDAMED 04042091000299|40420910001M33
- EUDAMED 04042091000305|40420910001M33