MeCross NC PTCA Balloon Dilatation Catheter
by Shenzhen Medoo Medical Tech. Co., Ltd
Ref MC-02-2008Model MC-02-2008,MC-02-2010,MC-02-2012,MC-02-2015,MC-02-2018,MC-02-2208,MC-02-2210,MC-02-2212,MC-02-2215,MC-02-2218,MC-02-2508,MC-02-2510,MC-02-2512,MC-02-2515,MC-02-2518,MC-02-2708,MC-02-2710,MC-02-2712,MC-02-2715,etc
Active
CE MDR
Valid until
16 Sep 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 786406 | Date17 Sep 2026 | StatusActive |
Certificates
- MDR 786406 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 17 Sep 2026
- Expires
- 16 Sep 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- MeCross NC PTCA Balloon Dilatation Catheter
- Model / Reference
- MC-02-2008, MC-02-2010, MC-02-2012, MC-02-2015, MC-02-2018, MC-02-2208, MC-02-2210, MC-02-2212, MC-02-2215, MC-02-2218, MC-02-2508, MC-02-2510, MC-02-2512, MC-02-2515, MC-02-2518, MC-02-2708, MC-02-2710, MC-02-2712, MC-02-2715, etc
- Primary DI / UDI-DI
- 06973710640498
- Basic UDI-DI
- 697371064MC02H7
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000011452
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Medoo Medical Tech. Co., Ltd
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No