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by Zevex Inc. United States EUDAMED

Ref S412 EMDN Z12030380

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number08148440082317LJ Basic UDI-DI	Date19 Apr 2023Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Enteral Accessories
Model / Reference: S412

Primary DI / UDI-DI: 10814844001782
Basic UDI-DI: 08148440082317LJ
EMDN Code: Z12030380 Infusion instruments - hardware accessories

Device Class: Class I
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: US-MF-000005937
Authorised representative: Abbott Ireland IE-AR-000004255

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Non-DEHP Microbore Admin Set, Non-Vent Spike, Y-Site with Check Valve

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Non-DEHP Admin Set, Vented .2 μ Filter, Vented Vial Spike

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Properties & raw data

Show properties, registry sources and raw records

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (1)

EUDAMED 27adecdd-5542-4bd4-bf73-39219adcc012 61 fields · synced 24 Oct 2026