Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

ZELOSTAT Needle

UDI-DI 04582542160061Basic UDI-DI 458254216004CB

Class IIa · MDR · ASTI CORPORATION

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Identification

Model: ZELOSTAT Needle 35G
EMDN: A01010199
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

ZELOSTAT Needle 04582542160115
ZELOSTAT Needle 04582542160047
ZELOSTAT Needle 04582542160108
ZELOSTAT Needle 04582542160085
ZELOSTAT Needle 04582542160054
ZELOSTAT Needle 04582542160078
ZEROSTAT Needle 04582542160092

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/zelostat-needle-0061 · UDI page: /udi/04582542160061

All devices from ASTI CORPORATION

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