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Pre-filled flush syringe
EUDAMEDClass IIa (EU MDR)
Ref PFF10SPZRef PFF03SPZRef catheflush5mlRef PFF05SPZ
Identity
- Trade Name
- Pre-filled flush syringe EUDAMED
- Device Name
- SOL-CARE Pre-filled Flush Syringe 0.9% Sodium Chloride Sterile Fluid Path EUDAMEDPre-filled Flush Syringe EUDAMED
- Model / Reference
- PFF10SPZ EUDAMEDPFF03SPZ EUDAMEDcatheflush5ml EUDAMEDPFF05SPZ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971911021405 EUDAMED06971911021436 EUDAMED06971911021054 EUDAMED06971911021450 EUDAMED
- Basic UDI-DI
- B-06971911021405 EUDAMEDB-06971911021436 EUDAMED697191102catheflushHE EUDAMEDB-06971911021450 EUDAMED
- Direct Marketing DI
- 26971911021058 EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Pre-filled flush syringe by Jiangsu Embrace Science&Technology Development Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.
- BAL Flush Spritze 10ml DS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Burg Pharma — Jiangsu Caina Medical Co.,Ltd. · Class IIa
- BAL Flush Spritze 5ml SS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp. · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class II
- EASY FLUSH — SPM MEDICARE PVT, LTD. · Class IIb
- Prefilled Syringe with 0.9% Saline Solution — Poly Medicure Limited · Class IIb
- KLINION — Jiangsu Caina Medical Co.,Ltd. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971911021405 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971911021405 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000020321
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (4)
- EUDAMED 7a3ada80-8d1b-4689-925d-b118a39cd7b6 61 fields · synced Aug 1, 2026
- EUDAMED ba40e9ff-6d25-4d4a-9dfd-c0db4a47bc83 61 fields · synced May 18, 2026
- EUDAMED 701acdf1-fcf5-45fc-b387-71e3e7f40a60 61 fields · synced May 19, 2026
- EUDAMED 1d39f8f9-3241-4542-9398-c283145db9bd 61 fields · synced May 19, 2026