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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

HyaRegen Gel

UDI-DI 06952181200196Basic UDI-DI 695218124001249

Class III · MDR · BioRegen Biomedical (Changzhou) Co., Ltd.

Identification
Model
2ml, 3ml, 5ml, 6ml, 8ml, 10ml, 15ml, 20ml
EMDN
M0406
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

G70 070340 0012

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2024-11-14 · Expiry 2029-11-13

Scope not stated in certificate data.

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

Manufacturer

BioRegen Biomedical (Changzhou) Co., Ltd.

SRN CN-MF-000007975

CN · Changzhou, Jiangsu

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hyaregen-gel-0196 · UDI page: /udi/06952181200196

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