Unknown / Not in EUDAMED

Snapshot 2026-10-18 · Link to EUDAMED

Zygomatic implant

UDI-DI +D748141EZ35A0HBasic UDI-DI ++D748ZYGRHIMPLSWM

Class IIb · MDR · BIOTEC S.R.L.

Scan an inventory CSV

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

Related UDI-DIs

Zygomatic implant +D748133IR37D0J
Zygomatic implant +D748141EZ35H0O
Zygomatic implant +D748133IR37G0M
Zygomatic implant +D748142EZ35I0Q
Zygomatic implant +D748141EZ35M0T
Zygomatic implant +D748141EZ35F0M
Zygomatic implant +D748141EZ35K0R
Zygomatic implant +D748142EZ35G0O
Zygomatic implant +D748142EZ35M0U
Zygomatic implant +D748141EZ35D0K
Zygomatic implant +D748133IR37C0I
Zygomatic implant +D748142EZ35A0I

Showing 12 of 32 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/zygomatic-implant-5A0H · UDI page: /udi/%2BD748141EZ35A0H

All devices from BIOTEC S.R.L.

Scan an inventory CSV