Bexcore Fast Kit
by MedicalPark CO., LTD. EUDAMED
Active
Ref BXF14, BXF16, BXFG1410, BXFG1610
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000259012NX | Date4 Nov 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Sterile Single-use Core Biopsy Instrument kit
- Model / Reference
- BXF14, BXF16, BXFG1410, BXFG1610
- Primary DI / UDI-DI
- 08800025900680
- Basic UDI-DI
- 88000259012NX
- EMDN Code
- A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- KR-MF-000026310
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Other devices from Medical Park Co., Ltd.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No