FirefighterTM
by Shanghai MicroPort Medical (Group) Co., Ltd. 7 variants
Ref RF1020
Active
CE MDR CE MDD
Valid until
9 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-06939963810033 | Date23 May 2023 | StatusActive |
| European Union | CE/MDD | NumberB-06939963810033 | Date23 May 2023 | StatusActive |
Certificates
- G70 115436 0003 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 10 Jan 2023
- Expires
- 9 Jan 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- FirefighterTMFirefighter
- Device Name
- Firefighter PTCA Balloon CathetersFirefighter PTCA Ballnoon Catheter
- Model / Reference
- RF1020
- Primary DI / UDI-DI
- 06939963810033, 06942180398352
- Basic UDI-DI
- B-06939963810033, 69421803C0B09AY
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU 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
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