Hypodermic syringe for single use with needle
by Changzhou Holinx Industries Co., Ltd 3 variants
Ref HIS1-2913Model 1ML INSULIN,1ML,2ML,2.5ML,5ML,10ML,20ML,22ML,24ML,25ML,30ML,35ML,50L,60ML,100ML
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 | Number697251834ZSQW2 06972518341781 | Date4 Aug 2025 | 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- Withdrawn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
- Hypodermic syringe for single use with needle
- Model / Reference
- 1ML INSULIN, 1ML, 2ML, 2.5ML, 5ML, 10ML, 20ML, 22ML, 24ML, 25ML, 30ML, 35ML, 50L, 60ML, 100ML, HIS1-2913
- Primary DI / UDI-DI
- 06972518341781
- Basic UDI-DI
- 697251834ZSQW2
- Direct Marketing DI
- 06972518341781
- EMDN Code
- A02010204 Infusion and irrigation syringes, without cone, with fixed needle, single-use
- Device Class
- Class IIa
- 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