Infusion sets for single use
by Jiangxi Hongda Medical Equipment Group Ltd. 11 variants
Ref B201PNModel B2
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 | Number69207567GSYQ00029B 66920756700268 | Date4 Oct 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- Withdrawn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
- Model / Reference
- B2, B201PN
- Primary DI / UDI-DI
- 66920756700268
- Basic UDI-DI
- 69207567GSYQ00029B
- EMDN Code
- A03010199 Infusion controllers - other
- Device Class
- Class IIb
- EU market of registration
- Hungary
Manufacturer details
- EUDAMED SRN
- CN-MF-000006019
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangxi Hongda Medical Equipment Group Co., Ltd.
See all devices from Jiangxi Hongda Medical Equipment Group Co., Ltd. →
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No