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Syringe NaCl 0, 9% Luer Lock 10 ml (3ml fill)
EUDAMEDClass IIa (EU MDR)
Ref 3990120
Identity
- Trade Name
- Syringe NaCl 0,9% Luer Lock 10 ml (3ml fill) EUDAMED
- Device Name
- Syringes with 0.9% sodium chloride EUDAMED
- Model / Reference
- 3990120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05608120026532 EUDAMED
- Basic UDI-DI
- 5608120PFSNACL0.9IIAV47TJ EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Syringe NaCl 0, 9% Luer Lock 10 ml (3ml fill) by Sterisets Manufacturing S.A. — Class IIa — 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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- 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
Manufacturer's product page: Pre-filled syringes
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 | 5608120PFSNACL0.9IIAV47TJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterisets Manufacturing S.A.
- EUDAMED SRN
- PT-MF-000002822
Sources (1)
- EUDAMED 574aba1c-0630-4cbb-89a1-a8bc0921fa79 61 fields · synced Jul 15, 2026