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Uniz

EUDAMED

Class I (EU MDR)

Ref zDental IDBModel zDental IDB zDental IDB Hard zDental IDB SoftRef zDental Try-In A1Model zDental Try-In A1 zDental Try-In A2 zDental Try-In A3 zDental Try-In Bleach zDental Try-In BL1Ref zDental Tray

by Uniz Technology (Beijing) Co., Ltd.

Identity

Trade Name
UNIZ EUDAMED
Device Name
zDental IDB EUDAMED
zDental Try-In EUDAMED
zDental Tray EUDAMED
Model / Reference
zDental IDB zDental IDB Hard zDental IDB Soft EUDAMED
zDental IDB EUDAMED
zDental Try-In A1 zDental Try-In A2 zDental Try-In A3 zDental Try-In Bleach zDental Try-In BL1 EUDAMED
zDental Try-In A1 EUDAMED
zDental Tray EUDAMED

Identifiers

Primary DI / UDI-DI
06971687880411 EUDAMED
06971687881210 EUDAMED
06971687880817 EUDAMED
Basic UDI-DI
697168788IDBWT EUDAMED
697168788TryInA1GL EUDAMED
697168788Tray8Z EUDAMED
EMDN Code
Q0102050101,Q0102050102,Q0102050199 EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Uniz by Uniz Technology (Beijing) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000039351
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 9e1f2992-fe50-40be-bfb2-694789fd824f 61 fields · synced Aug 2, 2026
  • EUDAMED bb8b37f7-29d2-479c-b772-67f8d0d9187c 61 fields · synced May 19, 2026
  • EUDAMED 014c0535-47ff-4f68-86db-36973d13d7b0 61 fields · synced May 19, 2026