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K50 International

EUDAMED

Class IIa (EU MDR)

Ref 71MF0000, 71MS0000Model Dental Units

by CEFLA s.c.

Identity

Trade Name
K50 INTERNATIONAL EUDAMED
Model / Reference
Dental Units EUDAMED
71MF0000, 71MS0000 EUDAMED

Identifiers

Primary DI / UDI-DI
08033837934011 EUDAMED
Basic UDI-DI
803383793TRDENTUNA001QY EUDAMED
Direct Marketing DI
08033837934011 EUDAMED
EMDN Code
Z12110101 DENTAL TREATMENT UNITS EUDAMED

Classification

Device Class
Class IIa 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

Category: Dental delivery system

K50 International by CEFLA s.c. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental delivery system.

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 (2)

  • EUDAMED 8f319a6d-9c00-4521-876f-3d39445d3128-1 61 fields · synced Jul 10, 2026
  • EUDAMED 8f319a6d-9c00-4521-876f-3d39445d3128-2 61 fields · synced Jul 10, 2026