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Major Plus V X8 Lower B4-Hal

EUDAMED

Class IIa (EU MDR)

Ref T2012.B4.HAL.LModel Acrylic resin artificial teeth

by Major Prodotti Dentari S.p.A.

Identity

Trade Name
MAJOR PLUS V X8 LOWER B4-HAL EUDAMED
Device Name
Major Plus, Major Super Lux, Major Dent, Bambino tooth EUDAMED
Model / Reference
Acrylic resin artificial teeth EUDAMED
T2012.B4.HAL.L EUDAMED

Identifiers

Primary DI / UDI-DI
08056640054776 EUDAMED
Basic UDI-DI
8056640TEEGF EUDAMED
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER 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

Major Plus V X8 Lower B4-Hal by Major Prodotti Dentari S.p.a. — Class IIa — 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
IT-MF-000024700

Sources (1)

  • EUDAMED 2f4949e4-ebb8-4521-b0a1-f6944e188ce4 61 fields · synced Aug 1, 2026