Disposable Endoscopic Trocar
by Fengh Medical Co., Ltd. 16 variants
Ref FH07Model BT Series, AR Series, BSPC5,BLPC5,BXPC5,BSPC8,BLPC8,BXPC8,BSPC10,BLPC10,BXPC10,BSPC11,BLPC11,BXPC11,BSPC12,BLPC12,BXPC12,BSPC15,BLPC15,BXPC15
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69213483FH0701E5W | Date7 Sep 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Disposable Endoscopic TrocarDisposable Endoscopic Trocars
- Model / Reference
- BT Series, AR Series, FH07, BSPC5, BLPC5, BXPC5, BSPC8, BLPC8, BXPC8, BSPC10, BLPC10, BXPC10, BSPC11, BLPC11, BXPC11, BSPC12, BLPC12, BXPC12, BSPC15, BLPC15, BXPC15
- Primary DI / UDI-DI
- 06921348304473, 06921348332612, 06921348332438, 06921348332650, 06921348304589, 06921348332711, 06921348332773, 06921348332490, 06921348304374, 06921348332704, 06921348304442, 06921348332810, 06921348304534, 06921348332780
- Basic UDI-DI
- 69213483FH0701E5W, 69213483FH0704E67
- EMDN Code
- K01010101 Trocar standard, single-use
- Device Class
- Class IIa
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000004718
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Fengh Medical 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