TTK Chitra Mechanical Heart Valve
by TTK Healthcare Limited Heart Valve Division EUDAMED
Active
Ref 31MHModel Model TC1-H (with Pre-mounted holder)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08902618004536 | Date8 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 31mm
- Model / Reference
- Model TC1-H (with Pre-mounted holder), 31MH
- Primary DI / UDI-DI
- 08902618004536
- Basic UDI-DI
- B-08902618004536
- EMDN Code
- P07030202 Mechanical heart valves, single-disc
- Device Class
- Class III
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- IN-MF-000022265
- Authorised representative
- Obelis s.a. BE-AR-000000106
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Properties
Other properties (9)
- 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