Tokai Microcatheter, Carnelian 2.2
by Tokai Medical Products, Inc. 10 variants
Ref MCV150M-E
Active
CE MDR CE MDD
Valid until
31 Mar 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberJP25/00000098 | Date22 Sep 2025 | StatusActive |
| European Union | CE/MDD | NumberB-04562382431958 04562382431958 | Date16 May 2022 | StatusActive |
Certificates
- JP25/00000098 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 22 Sep 2025
- Expires
- 31 Mar 2030
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Tokai Microcatheter
- Model / Reference
- MCV150M-E
- Primary DI / UDI-DI
- 04562382431958
- Basic UDI-DI
- B-04562382431958, 456238243MCTR
- EMDN Code
- C0104020101, C0104020202, C0104020205
- Device Class
- Class IIa
- EU market of registration
- GermanySweden
Manufacturer details
- EUDAMED SRN
- JP-MF-000011106
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Tokai Medical Products, Inc.
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