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UDI Compass

HELYSIS

Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 08903837092151Basic UDI-DI 8903837HML006WY

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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

2024-MDR/TD-042/A

EU technical documentation assessment · unknown

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

Valid from 2025-11-28 · Expiry 2029-03-22

Scope not stated in certificate data.

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

2024-MDR/QS-042/A

EU quality management system · unknown

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

Valid from 2025-11-28 · Expiry 2029-03-22

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

NameUDI-DICertificate
HELYSIS08903837092144
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/helysis-2151 · UDI page: /udi/08903837092151

All devices from HEALTHIUM MEDTECH LIMITED