Skip to content
UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Cross-Linked HA Soft Tissue Filing Gel

UDI-DI 08809427070465Basic UDI-DI 880942707ACVLLE

Class III · MDR · Across Co., Ltd.

Identification
Model
VOLUS 10™
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2025-MDR/TD-002/A

EU technical documentation assessment · unknown

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

Valid from 2026-08-17 · Expiry 2030-01-17

Scope not stated in certificate data.

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

2025-MDR/QS-002/A

EU quality management system · unknown

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

Valid from 2026-08-17 · Expiry 2030-01-17

Scope not stated in certificate data.

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

Manufacturer

Across Co., Ltd.

SRN KR-MF-000012936

KR · Chuncheon-si, Gangwon-do

manufacturer

Authorised representative: Javitech Consulting GmbH (DE-AR-000045915)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cross-linked-ha-soft-tissue-filing-gel-0465 · UDI page: /udi/08809427070465

Scan an inventory CSV