← Back to catalogue

Ortéza zápästia s výstuhou dlaňovej strany , Sohatex, ĽAVÁ, ZA-31

EUDAMED

Class I (EU MDR)

Ref J 80831Model Wrist-hand orthose

by PROTETIKA, a.s.

Identity

Trade Name
Ortéza zápästia s výstuhou dlaňovej strany , Sohatex, ĽAVÁ, ZA-31 EUDAMED
Ortéza zápästia s výstuhou dlaňovej strany, Sohatex, ĽAVÁ,ZA-31 EUDAMED
Model / Reference
Wrist-hand orthose EUDAMED
J 80831 EUDAMED

Identifiers

Primary DI / UDI-DI
08585003408210 EUDAMED
08585003408173 EUDAMED
Basic UDI-DI
858500J80831ZA31LL3G EUDAMED
858500J80831ZA31LS3W EUDAMED
Direct Marketing DI
08585003408210 EUDAMED
08585003408173 EUDAMED
EMDN Code
Y060612 WRIST-HAND ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Slovakia 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

Ortéza zápästia s výstuhou dlaňovej strany , Sohatex, ĽAVÁ, ZA-31 by PROTETIKA, a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
PROTETIKA, a.s.
EUDAMED SRN
SK-MF-000004489

Sources (2)

  • EUDAMED 7a0e90a5-05dd-4d31-a6e5-02c9e048379f 61 fields · synced Oct 6, 2026
  • EUDAMED f6042a86-2fb8-4086-95db-058c2bae9a50 61 fields · synced May 17, 2026