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Pre-fillefd flush syringe
EUDAMEDClass IIa (EU MDR)
Ref 3030005Model 5mlRef 3030003Model 3mlRef catheflush3ml-BModel Pre-filled flush syringe 3ml, 5ml, 10mlRef 3030010Model 10mlRef SPS0001
Identity
- Trade Name
- Pre-fillefd flush syringe EUDAMEDPre-fillefd flush syringe (B001-MY) EUDAMED
- Device Name
- Pre-filled flush syringe Brightline Med EUDAMEDPre-filled Flush Syringe EUDAMED
- Model / Reference
- 5ml EUDAMED3030005 EUDAMED3ml EUDAMED3030003 EUDAMEDPre-filled flush syringe 3ml, 5ml, 10ml EUDAMEDcatheflush3ml-B EUDAMED10ml EUDAMED3030010 EUDAMEDSPS0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971911025816 EUDAMED06971911020804 EUDAMED16971911023208 EUDAMED06971911021078 EUDAMED06971911020446 EUDAMED
- Basic UDI-DI
- B-06971911025816 EUDAMEDB-06971911020804 EUDAMED697191102PS0000001JD EUDAMEDB-06971911021078 EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDFrance 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-fillefd 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.
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- 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-06971911025816 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971911025816 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000020321
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (5)
- EUDAMED f205a140-9c83-4f12-ab06-63678dadc439 61 fields · synced Jul 26, 2026
- EUDAMED 2079708e-6e9a-404f-97c7-d9789e44a54c 61 fields · synced May 17, 2026
- EUDAMED 991e3bb6-9b3c-4ff6-a91c-313fd8da8304 61 fields · synced May 18, 2026
- EUDAMED 216aaf92-5df8-4700-af00-1dc22d55909c 61 fields · synced May 18, 2026
- EUDAMED ae186dd7-d3df-4f8f-b617-40b1c664a246 61 fields · synced May 19, 2026