Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Comb Tip Tyvek Pouch

UDI-DI 08809447658100Basic UDI-DI 88094476510505AWD

Class IIb · MDR · Lutronic Corporation

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Identification

Model: MOSAIC 3D
EMDN: Z12011099
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2975-MED-2601901

EU quality management system · unknown

Notified body: SZUTEST Konformitätsbewertungsstelle GmbH (2975)

Valid from 2026-09-22 · Expiry 2031-01-18

Scope not stated in certificate data.

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

Manufacturer

Lutronic Corporation

SRN KR-MF-000009035

KR · Deogyang-gu, Goyang-si, Gyeonggi-do

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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Pill Tip 08809447656960
Pill Tip BOX 08809447657127
Pill Tip Package 08809447657424
Pill Tip Tyvek Pouch 08809447658117
Roller Tip 08809447656946
Roller Tip BOX 08809447657103
Roller Tip Package 08809447658056
Roller Tip Tyvek Pouch 08809447658094

Showing 12 of 21 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/comb-tip-tyvek-pouch-8100 · UDI page: /udi/08809447658100

All devices from Lutronic Corporation

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