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SIRINGA PRERIEMPITA 3 ML 0, 9% NaCl- PENTAFLUSH
EUDAMEDClass IIb (EU MDR)
Ref 060022424
Identity
- Trade Name
- SIRINGA PRERIEMPITA 3 ML 0,9% NaCl- PENTAFLUSH EUDAMED
- Device Name
- SIRINGA PRERIEMPITA EUDAMED
- Model / Reference
- 060022424 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015262000196 EUDAMED
- Basic UDI-DI
- 801526210854 EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
SIRINGA PRERIEMPITA 3 ML 0, 9% NaCl- PENTAFLUSH by Pentaferte Italia Srl — Class IIb — MDR — 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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- 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
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 | 801526210854 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Pentaferte Italia Srl
- EUDAMED SRN
- IT-MF-000040982
Sources (1)
- EUDAMED f7829557-896c-4b8c-8d99-dba6d8e50df0 61 fields · synced Jun 19, 2026