Bialmed
by Jiangsu Kanghua Medical Equipment Co., Ltd. 57 variants
Ref KM005LL, PSM4109BFModel 5ml, SXQ
Active
CE MDR CE MDD
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 | NumberB-06935491700167 06935491700167 | Date25 May 2026 | StatusActive |
| European Union | CE/MDD | NumberB-06935491700167 06935491700167 | Date25 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Disposable Syringes Withtout NeedleDisposable Transfusion Sets without Needle
- Model / Reference
- 5ml, KM005LL, SXQ, PSM4109BF
- Primary DI / UDI-DI
- 06935491700167
- Basic UDI-DI
- B-06935491700167, 693549172400KC
- EMDN Code
- A020102020102, A03010102
- Device Class
- Class IClass IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000033842
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangsu Kanghua Medical Equipment Co., Ltd.
See all devices from Jiangsu Kanghua Medical Equipment 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