RHCE BeadChip Kit
by BioArray Solutions Ltd EUDAMED
Active
Ref 800-10206-48
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-00850081948728 | Date4 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- RHCE BeadChip Kit (Slide 6x8,CE)
- Model / Reference
- 800-10206-48
- Primary DI / UDI-DI
- 00850081948728
- Basic UDI-DI
- B-00850081948728
- EMDN Code
- W01030499 Tissue typing reagents - other
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000022068
- Authorised representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Other devices from Bioarray Solutions Ltd
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No