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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Dr. INVIVO AI Regen KIT

UDI-DI 08809692500186Basic UDI-DI 880969250DrINVIVOARKVJ

Class IIa · MDR · ROKIT HEALTHCARE Inc.

Identification
Model
ARK-001, ARK-002
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

2023-MDR/QS-013/A

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2026-01-30 · Expiry 2028-07-03

Scope not stated in certificate data.

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

Manufacturer

ROKIT HEALTHCARE Inc.

SRN KR-MF-000009720

KR · Geumcheon-Gu, Seoul

manufacturer

Authorised representative: AR Experts B.V. (NL-AR-000023989)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/dr-invivo-ai-regen-kit-0186 · UDI page: /udi/08809692500186

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