NC Loach
by Shunmei Medical Co., Ltd 111 variants
Ref 643821
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The NC Loach balloon dilatation catheter is a highly specialized medical device designed for the administration of non-sterile, sterile, or reposable treatments in various medical specialties. It features advanced technology and precision engineering, ensuring accurate and reliable performance in both clinical settings and research environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06956014438213 06956014438213 | Date28 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- Withdrawn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/MDD Active
Specification
- Model / Reference
- 643821
- Primary DI / UDI-DI
- 06956014438213
- Basic UDI-DI
- B-06956014438213
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000001160
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shunmei Medical Co., Ltd
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No