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Easy Flush
EUDAMEDClass IIb (EU MDR)
Ref 1BV7B5DModel 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Ribbon pack (Sterile Fluid Path) and 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Blister pack, (Externally Sterile)
Identity
- Trade Name
- EASY FLUSH EUDAMED
- Device Name
- Flush Syringe (Prefilled 0.9 % saline solution) EUDAMED
- Model / Reference
- 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Ribbon pack (Sterile Fluid Path) and 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Blister pack, (Externally Sterile) EUDAMED1BV7B5D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904379807968 EUDAMED
- Basic UDI-DI
- 89043798FSHEYE EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Easy Flush by Spm Medicare Pvt, Ltd. — Class IIb — MDR — 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
- Pre-fillefd flush syringe(B001-MY) — Jiangsu Embrace Science&Technology Development 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
- 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 | 89043798FSHEYE | Class IIb | Active |
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Manufacturer
- Manufacturer
- SPM Medicare Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000011829
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED cadf3224-1d9f-4116-910f-38fcc234bb6c 61 fields · synced Jul 8, 2026