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OptiSCAN WL

EUDAMED

Class I (EU MDR)

Ref 7098B003Model Intraoral scanner

by CEFLA s.c.

Identity

Trade Name
OptiSCAN WL EUDAMED
Model / Reference
Intraoral scanner EUDAMED
7098B003 EUDAMED

Identifiers

Primary DI / UDI-DI
08033837937166 EUDAMED
Basic UDI-DI
803383793IMINTRSC1001D2 EUDAMED
Direct Marketing DI
08033837937166 EUDAMED
EMDN Code
Z110601 LASER IMAGING SCANNER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy 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

OptiSCAN WL by CEFLA s.c. — 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

Manufacturer
CEFLA s.c.
EUDAMED SRN
IT-MF-000009228

Sources (1)

  • EUDAMED 8da0804b-eb69-4e56-9e51-11abcb8004ab 61 fields · synced Jul 14, 2026