Disposable irrigation syringe
by Changzhou Holinx Industries Co., Ltd 2 variants
Ref HIR50Model 20ML,50ML,60ML,100ML,150ML,200ML
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 | Number697251834IR2W 06972518341750 | Date28 Aug 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- Withdrawn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 Active
Specification
- Device Name
- Disposable irrigation syringe
- Model / Reference
- 20ML, 50ML, 60ML, 100ML, 150ML, 200ML, HIR50
- Primary DI / UDI-DI
- 06972518341750
- Basic UDI-DI
- 697251834IR2W
- Direct Marketing DI
- 06972518341750
- EMDN Code
- A02010203 Infusion and irrigation syringes, catheter cone, single-use
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000041593
- Authorised representative
- Eunitor GmbH DE-AR-000005081
Other devices from Changzhou Holinx Industries Co., Ltd
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Incorporates Medicinal Product: No