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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

TRULENE

UDI-DI 08903837820747Basic UDI-DI 8903837H010201010426

Class III · MDR · HEALTHIUM MEDTECH LIMITED

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

2022-MDR/TD-011/C

EU technical documentation assessment · unknown

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

Valid from 2025-07-10 · Expiry 2027-08-15

Scope not stated in certificate data.

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

2022-MDR/QS-011/C

EU quality management system · unknown

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

Valid from 2025-07-10 · Expiry 2027-08-15

Scope not stated in certificate data.

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

Manufacturer

HEALTHIUM MEDTECH LIMITED

SRN IN-MF-000008421

IN · Bangalore

manufacturer

Authorised representative: Meddevices Lifesciences B.V. (NL-AR-000000594)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/trulene-0747 · UDI page: /udi/08903837820747

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