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PCF polyaxial pedicle screw

EUDAMED

Class IIb (EU MDR)

Ref 800043540Model WGB1Z-4

by Shandong Weigao Orthopaedic Device Company Limited.

Identity

Trade Name
PCF polyaxial pedicle screw EUDAMED
Device Name
Sterile and Non Sterile Spinal System EUDAMED
Model / Reference
WGB1Z-4 EUDAMED
800043540 EUDAMED

Identifiers

Primary DI / UDI-DI
06912547463597 EUDAMED
Basic UDI-DI
6903095SPIWGB1Z4PP6N EUDAMED
EMDN Code
P09070301 CERVICAL FIXATION SYSTEMS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Lithuania 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

Category: Cervical spine immobilization system, single-use

PCF polyaxial pedicle screw by Shandong Weigao Orthopaedic Device Company Limited. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Cervical spine immobilization system, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Shandong Weigao Orthopaedic Device Company Limited.
EUDAMED SRN
CN-MF-000019785
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 2b6d35fd-abac-4e38-8751-0f58591377c0 61 fields · synced Jun 18, 2026