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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

HYDRAFIL Procedure Kit

UDI-DI 00195893334186Basic UDI-DI 0195893BM2022FG

Class III · MDR · ReGelTec Inc.

Identification
Model
610-0003
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

28620211491

EU technical documentation assessment · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2025-05-05 · Expiry 2027-11-28

Scope not stated in certificate data.

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

Manufacturer

ReGelTec Inc.

SRN US-MF-000025182

US · Baltimore

manufacturer

Authorised representative: Advena Limited (MT-AR-000000234)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hydrafil-procedure-kit-4186 · UDI page: /udi/00195893334186

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