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Prefilled flush syringe (B001-MY)
EUDAMEDClass IIa (EU MDR)
Ref SPS0003Model Pre-filled flush syringe 3ml, 5ml, 10ml
Identity
- Trade Name
- Prefilled flush syringe (B001-MY) EUDAMED
- Device Name
- Pre-filled Flush Syringe EUDAMED
- Model / Reference
- Pre-filled flush syringe 3ml, 5ml, 10ml EUDAMEDSPS0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971911020460 EUDAMED
- Basic UDI-DI
- 697191102PS0000001JD EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Prefilled flush syringe (B001-MY) by Jiangsu Embrace Science&Technology Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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
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- 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697191102PS0000001JD | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000020321
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED d2b66e09-6837-4891-9402-b5d8cc2f3cd2 61 fields · synced Jun 18, 2026