immuClone (2) Anti-K Automated IgM
by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED
Ref 0066038
EMDN W0103030501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 1191616-11 | Date9 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 1191616-11 Supplemented
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 9 Apr 2026
- Expires
- 24 May 2028
- Reason
- Other
Specification
- Device Name
- immuClone (2) Anti-K IgM and Automated
- Model / Reference
- 0066038
- Primary DI / UDI-DI
- 10888234301479, 04042091000275
- Basic UDI-DI
- 88823405W0103030501D31KC, 40420910002M36
- Direct Marketing DI
- 1088823430147904042091000275
- 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 (2)
- EUDAMED 0e548f27-34c8-4494-aa17-2085502ff3ad
- EUDAMED 04042091000275|40420910002M36