Biomedical Coronary Injector
by Maccore Medi̇kal İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
Ref BMK-002Model Maccore, Morpho, Biomedical
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8683604114D019U 08683604114292 | Date8 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Manifold Kit Set
- Model / Reference
- Maccore, Morpho, Biomedical, BMK-002
- Primary DI / UDI-DI
- 08683604114292
- Basic UDI-DI
- 8683604114D019U
- EMDN Code
- A02010401 Syringes for contrast media injector, single-use
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000036830
Other devices from Maccore Medi̇kal İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
See all devices from Maccore Medi̇kal İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Incorporates Medicinal Product: No