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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

ZEROSTAT Needle

UDI-DI 04582542160092Basic UDI-DI 458254216004CB

Class IIa · MDR · ASTI CORPORATION

Identification
Model
ZELOSTAT Needle 35G
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

4204190CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-07-25 · Expiry 2027-12-08

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

ASTI CORPORATION

SRN JP-MF-000007443

JP · Hamamatsu, Shizuoka

manufacturer

Authorised representative: Advena Limited (MT-AR-000000234)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/zerostat-needle-0092 · UDI page: /udi/04582542160092

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