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Plantillas anatómicas antideslizantes, M

EUDAMED

Class I (EU MDR)

Ref P441 M

by Prim, S.a.

Identity

Trade Name
Plantillas anatómicas antideslizantes, M EUDAMED
Device Name
Ortesis Podológicas/Podiatry Orthoses EUDAMED
Model / Reference
P441 M EUDAMED

Identifiers

Primary DI / UDI-DI
08426680857918 EUDAMED
Basic UDI-DI
843404825PRODUCTOSPIEV7 EUDAMED
EMDN Code
Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED

Classification

Device Class
Class I 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

Category: Orthotic insole, prefabricated, non-antimicrobial

Plantillas anatómicas antideslizantes, M by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthotic insole, prefabricated, non-antimicrobial.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Prim, S.a.
EUDAMED SRN
ES-MF-000004651

Sources (1)

  • EUDAMED e57f971b-334d-4c0e-b27c-cd5ab5210a13 61 fields · synced Jul 24, 2026