Pre-filled flush syringe
by Jiangsu Embrace Science&Technology Development Co., Ltd. EUDAMED
Active
Ref PFF05SPZ
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06971911021450 | Date7 Aug 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- SOL-CARE Pre-filled Flush Syringe 0.9% Sodium Chloride Sterile Fluid Path
- Model / Reference
- PFF05SPZ
- Primary DI / UDI-DI
- 06971911021450
- Basic UDI-DI
- B-06971911021450
- EMDN Code
- A02010701 Prefilled syringes with sterile physiological solution
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000020321
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No