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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

i-Synth Fast

UDI-DI 08904300136464Basic UDI-DI 890430012015ULSSS0124N

Class III · MDR · Unisur Lifecare Private Limited

Identification
Model
12F75DZ20U
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2025-MDR/TD-027/A

EU technical documentation assessment · unknown

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

Valid from 2026-01-08 · Expiry 2030-04-24

Scope not stated in certificate data.

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

2025-MDR/QS-027/A

EU quality management system · unknown

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

Valid from 2026-01-08 · Expiry 2030-04-24

Scope not stated in certificate data.

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

Manufacturer

Unisur Lifecare Private Limited

SRN IN-MF-000008184

IN · Bangalore, Karnataka

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

Related UDI-DIs

Showing 12 of 86 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/i-synth-fast-6464 · UDI page: /udi/08904300136464

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