Pre-filled Flush Syringe
by Henan Tuoren-XinHui Medical Technology Co., Ltd. EUDAMED
Active
Ref TR-5mlModel TR-3ml、TR-5ml、TR-10ml
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6973219501C9 | Date10 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- TR-3ml、TR-5ml、TR-10ml, TR-5ml
- Primary DI / UDI-DI
- 06973219510605
- Basic UDI-DI
- 6973219501C9
- Direct Marketing DI
- 06973219510605
- EMDN Code
- A02010701 Prefilled syringes with sterile physiological solution
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000047128
- Authorised representative
- Medwheat Tech Service GmbH DE-AR-000006844
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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