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Neoprénová ortéza kolena KO-12

EUDAMED

Class I (EU MDR)

Ref J 53692Model Knee orthoseRef 8585003409576

by PROTETIKA, a.s.

Identity

Trade Name
Neoprénová ortéza kolena KO-12 EUDAMED
Neoprénová ortéza kolena, KO-12 EUDAMED
Model / Reference
Knee orthose EUDAMED
J 53692 EUDAMED
8585003409576 EUDAMED

Identifiers

Primary DI / UDI-DI
08585003412859 EUDAMED
08585003409569 EUDAMED
08585003409590 EUDAMED
08585003409576 EUDAMED
Basic UDI-DI
858500J53692KO12XXLP6 EUDAMED
858500J53692KO12SR3 EUDAMED
858500J53692KO12XL5H EUDAMED
858500J53692KO12MQP EUDAMED
Direct Marketing DI
08585003412859 EUDAMED
08585003409569 EUDAMED
08585003409590 EUDAMED
08585003409576 EUDAMED
EMDN Code
Y061209 KNEE 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

Neoprénová ortéza kolena KO-12 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

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Manufacturer

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

Sources (5)

  • EUDAMED 57f96abb-6fa3-4261-8566-6e0b288674a9 61 fields · synced Aug 1, 2026
  • EUDAMED da91be3e-990d-40a4-befa-489d4bf031ac 61 fields · synced May 17, 2026
  • EUDAMED 75509cdc-1faa-42e6-9adb-613ba49bcb4b 61 fields · synced May 19, 2026
  • EUDAMED bacfbb28-3df4-4890-8dff-964db903a9ee 61 fields · synced May 19, 2026
  • EUDAMED e70225cc-7e9e-4c38-8adf-e6fc3988e3f2 61 fields · synced Aug 1, 2026