Matrix Standard BT5 multi
by BIOTYPE GmbH
Ref 45-15100-0025, 45-15100-0050
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number42519352MATRIXSTANDBT5M8U | Date28 Mar 2025 | StatusActive |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 45-15100-0025, 45-15100-0050
- Primary DI / UDI-DI
- 04251935200751, 04251935200768
- Basic UDI-DI
- 42519352MATRIXSTANDBT5M8U
- EMDN Code
- W0580 IVD general use consumables devices - other accessories
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000025906
From the manufacturer
Manufacturer's product page: Matrix Standard BT5 multi
Other devices from BIOTYPE GmbH
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