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Ti-Base

EUDAMED

Class IIb (EU MDR)

Ref LITR008

by ARUM DENTISTRY Co., Ltd.

Identity

Trade Name
Ti-Base EUDAMED
Device Name
Abutment and Abutment screw EUDAMED
Model / Reference
LITR008 EUDAMED

Identifiers

Primary DI / UDI-DI
08800055723822 EUDAMED
Basic UDI-DI
88000557CADCAMAY EUDAMED
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

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

Ti-Base by ARUM DENTISTRY Co., Ltd. — Class IIb — 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
KR-MF-000009313
Authorised Representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Sources (1)

  • EUDAMED f4ec9c21-a300-462d-b383-69b0df1fb032 61 fields · synced Jul 13, 2026