ECG Cable and Leadwires
by Shenzhen Best Electronics Co., Ltd 5 variants
Ref BCY5-31IG, BCF5-09IG, BCYH5S-16IG, BCY5-34ISX, BCY3-13IG, BCY3-25IG, BCY3-37IG, BCF5-11IG, BCF5-23IG, BCY3-10IG, BCY5-62IG, BCY5-34IG, BCF6-11IG, BCZ3-01I, BCY5-01IG, BCF3-23IGModel BCYX-XXXX;BCFX-XXXX;BCZX-XXX
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 | Number697123682BCYX-XXXXWB | Date9 Mar 2024 | 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- Withdrawn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
- Device Name
- ECG Cable and Leadwires
- Model / Reference
- BCYX-XXXX, BCFX-XXXX, BCZX-XXX, BCY5-31IG, BCF5-09IG, BCYH5S-16IG, BCY5-34ISX, BCY3-13IG, BCY3-25IG, BCY3-37IG, BCF5-11IG, BCF5-23IG, BCY3-10IG, BCY5-62IG, BCY5-34IG, BCF6-11IG, BCZ3-01I, BCY5-01IG, BCF3-23IG
- Primary DI / UDI-DI
- 06971236827928, 06971236827379, 06971236821797, 06971236828246, 06971236821728, 06971236823319, 06971236828321, 06971236826648, 06971236824910, 06971236823364, 06977052222466, 06971236822053, 06971236821018, 06971236824118, 06971236820356, 06971236820998
- Basic UDI-DI
- 697123682BCYX-XXXXWB
- Direct Marketing DI
- 06971236827928069712368273790697123682179706971236828246069712368217280697123682331906971236828321069712368266480697123682491006971236823364069770522224660697123682205306971236821018069712368241180697123682035606971236820998
- EMDN Code
- Z1203020280 Multi-parameter monitors - hardware accessories
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000037463
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Best Electronics Co., Ltd
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No