FirefighterTM
by Shanghai MicroPort Medical (Group) Co., Ltd. China EUDAMED
Ref RF2006 EMDN C010401020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-06939963810125 | Date23 May 2023 | StatusActive |
| European Union | CE/MDD | NumberB-06939963810125 | Date23 May 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- G70 115436 0003 Issued
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 10 Jan 2023
- Expires
- 9 Jan 2028
Specification
- Trade Name
- FirefighterTMFirefighter
- Device Name
- Firefighter PTCA Balloon CathetersFirefighter PTCA Ballnoon Catheter
- Model / Reference
- RF2006
- Primary DI / UDI-DI
- 06939963810125, 06942180398444
- Basic UDI-DI
- B-06939963810125, 69421803C0B09AY
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000001110
- Authorised representative
- MicroPort Medical B.V. NL-AR-000000166
Other devices from Shanghai Microport Medical (Group) Co., Ltd
See all devices from Shanghai Microport Medical (Group) Co., Ltd →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED cb602662-5a29-4cc0-b833-6baabe8d91c3
- EUDAMED 06942180398444|69421803C0B09AY