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Bone Screws

EUDAMED

Class IIb (EU MDR)

Ref 42519028EModel 4.0mm Low profile cancellous screw, self-tappping, partial threads, Hex (titianium alloy),φ4.0×28

by Stryker Trauson (Changzhou) Medical Technology Co., Ltd.

Identity

Trade Name
Bone Screws EUDAMED
Device Name
4.0mm Low profile cancellous screw, self-tappping, partial threads, Hex (titianium alloy),φ4.0×28 EUDAMED
Model / Reference
4.0mm Low profile cancellous screw, self-tappping, partial threads, Hex (titianium alloy),φ4.0×28 EUDAMED
42519028E EUDAMED

Identifiers

Primary DI / UDI-DI
06931720478098 EUDAMED
Basic UDI-DI
B-06931720478098 EUDAMED
EMDN Code
P09120602 CANCELLOUS SCREWS EUDAMED

Classification

Device Class
Class IIb EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

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

Bone Screws by Stryker Trauson (Changzhou) Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000005689
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 91d796ec-8416-44b4-a6c2-2efae18939b2 61 fields · synced Sep 30, 2026