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Elephandens

EUDAMED

Class IIa (EU MDR)

Ref D8B458Model Artificial Teeth

by Union Dental S.a.

Identity

Trade Name
ELEPHANDENS EUDAMED
Model / Reference
Artificial Teeth EUDAMED
D8B458 EUDAMED

Identifiers

Primary DI / UDI-DI
08435288482484 EUDAMED
Basic UDI-DI
084352884UD-TEETHVS EUDAMED
EMDN Code
Q01020601,Q01020602,Q01020603,Q01020605 EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Spain 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

Elephandens by Union Dental S.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

Manufacturer
Union Dental S.a.
EUDAMED SRN
ES-MF-000003189

Sources (1)

  • EUDAMED 7bf3ee6b-bdcb-4111-ba4c-df20bfd239f7 61 fields · synced Jul 29, 2026