Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

AK-FIX

UDI-DI 18904210304899Basic UDI-DI 89042103cmplimp004XD

Class IIb · MDR · Chetan Meditech Pvt. Ltd.

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Identification

Model: Nonabsorbable Soft Tissue & Bone Fixation Devices - Fixation Buttons with/without Suture Loops
EMDN: H900301, P09120102
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

2024-MDR/TD-033

EU technical documentation assessment · valid

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

Valid from 2024-01-07 · Expiry 2029-01-07

Scope not stated in certificate data.

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

2024-MDR/QS-033

EU quality management system · valid

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

Valid from 2024-07-01 · Expiry 2029-07-01

Scope not stated in certificate data.

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

Manufacturer

Chetan Meditech Pvt. Ltd.

SRN IN-MF-000013541

IN · Ahmedabad, Gujarat

manufacturer

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

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BUTTONFIX 18904210301157
BUTTONFIX-F 18904210305438
BUTTONFIX-F 18904210302208
BUTTON-FIX Mini 18904210305827
BUTTONFIX-W 18904210302291
BUTTONFIX-W 18904210304479
MR-FIX 18904210302451

Showing 12 of 29 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ak-fix-4899 · UDI page: /udi/18904210304899

All devices from Chetan Meditech Pvt. Ltd.

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