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Proximal tibial plate +1 more model

EUDAMED

Class IIb (EU MDR)

Ref 397129782413Model PlateRef 397129782553

by MEDIN, a.s.

Identity

Trade Name
Proximal tibial plate; Ti, lateral 5, 225 mm, 14 holes, right EUDAMED
Proximal tibial plate; Ti, lateral 5, 225 mm, 14 holes, left EUDAMED
Device Name
Proximal tibial plate EUDAMED
Model / Reference
Plate EUDAMED
397129782413 EUDAMED
397129782553 EUDAMED

Identifiers

Primary DI / UDI-DI
08591712394591 EUDAMED
08591712394645 EUDAMED
Basic UDI-DI
85917126020801WJ EUDAMED
Direct Marketing DI
08591712394591 EUDAMED
08591712394645 EUDAMED
EMDN Code
P09120502 OSTEOSYNTHESIS NEUTRALISATION AND SUPPORT PLATES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Czechia EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

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

Proximal tibial plate +1 more model by MEDIN, a.s. — Class IIb — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
MEDIN, a.s.
EUDAMED SRN
CZ-MF-000012371

Sources (2)

  • EUDAMED cf96fce1-48fd-4bea-adee-e3920ed69d46 61 fields · synced Oct 6, 2026
  • EUDAMED 2d414522-c0c3-4bc5-90b0-7eef64d974e3 61 fields · synced May 16, 2026