Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Zygomatic implant

UDI-DI +D748142EZ35M0UBasic UDI-DI ++D748ZYGRHIMPLSWM

Class IIb · MDR · BIOTEC S.R.L.

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Identification

Model: ZYGOMAX, ZYGO-ROUND, ZYGO-FLAT
EMDN: P01020101
Issuing agency: HIBCC
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

008-00-04-MDR

EU technical documentation assessment · unknown

Notified body: ITALCERT SRL (0426)

Valid from 2026-03-05 · Expiry 2027-12-20

Scope not stated in certificate data.

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

007-00-06-MDR

EU quality management system · unknown

Notified body: ITALCERT SRL (0426)

Valid from 2026-04-27 · Expiry 2027-12-20

Scope not stated in certificate data.

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

Manufacturer

SRN IT-MF-000026774

IT · Povolaro di Dueville

manufacturer

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Zygomatic implant +D748133IR37G0M
Zygomatic implant +D748142EZ35I0Q
Zygomatic implant +D748142EZ35B0J
Zygomatic implant +D748133IR37A0G
Zygomatic implant +D748142EZ35K0S
Zygomatic implant +D748141EZ35A0H
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Showing 12 of 32 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/zygomatic-implant-5M0U · UDI page: /udi/%2BD748142EZ35M0U

All devices from BIOTEC S.R.L.

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