GKS PRIME FLEX: Trial Insert TOP AS - Size H-Ix10mm RIGHT - ORANGE

EUDAMED

Class IIa (EU MDR)

Ref S53641Ref S53642

by Permedica S.p.A

Identity

Trade Name: GKS PRIME FLEX: Trial Insert TOP AS - Size H-Ix10mm RIGHT - ORANGE EUDAMED
GKS PRIME FLEX: Trial Insert TOP AS - Size H-Ix10mm LEFT - ORANGE EUDAMED
Device Name: Trial Component EUDAMED
Model / Reference: S53641 EUDAMED
S53642 EUDAMED

Identifiers

Primary DI / UDI-DI: 08050323078066 EUDAMED
08050323078073 EUDAMED
Basic UDI-DI: B-08050323078066 EUDAMED
B-08050323078073 EUDAMED
EMDN Code: V06010102 KNEE PROSTHESES TESTING DEVICES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Italy EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

GKS PRIME FLEX: Trial Insert TOP AS - Size H-Ix10mm RIGHT - ORANGE by Permedica S.p.A — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-08050323078066	Class IIa	Active

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Manufacturer

Manufacturer: Permedica S.p.A
EUDAMED SRN: IT-MF-000008110

Sources (2)

EUDAMED 9882f3ae-07e0-469e-b124-bcacd1914bb7 61 fields · synced Jul 30, 2026
EUDAMED 61a9d0b0-3202-4449-88c8-69c67925c0b2 61 fields · synced May 17, 2026