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Prefilled Syringe with 0.9% Saline Solution
EUDAMEDClass IIb (EU MDR)
Ref 90317Model Prefilled Syringe with 0.9% Saline SolutionRef 90316Ref 90315
Identity
- Trade Name
- Prefilled Syringe with 0.9% Saline Solution EUDAMED
- Device Name
- Prefilled Syringe with 0.9% Saline Solution EUDAMED
- Model / Reference
- Prefilled Syringe with 0.9% Saline Solution EUDAMED90317 EUDAMED90316 EUDAMED90315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095903179 EUDAMED08902095903162 EUDAMED08902095903155 EUDAMED
- Basic UDI-DI
- 890209590315GJ EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Prefilled Syringe with 0.9% Saline Solution by Poly Medicure Limited — 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
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- 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
- 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 | 890209590315GJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043011
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED a15450f3-5df1-449c-9344-0c2d2c92577a 61 fields · synced Jul 24, 2026
- EUDAMED 77ff2ee0-3429-4385-9cd5-ffd2a74e2bc2 61 fields · synced May 19, 2026
- EUDAMED ceb211a7-c115-4e5b-906b-ee71a2ee5d45 61 fields · synced May 19, 2026