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Sterile and Non Sterile Spinal System

EUDAMED

Class IIb (EU MDR)

Ref 812033542Model WGB1Z-4

by Shandong Weigao Orthopaedic Device Company Limited.

Identity

Device Name
Sterile and Non Sterile Spinal System EUDAMED
Model / Reference
WGB1Z-4 EUDAMED
812033542 EUDAMED

Identifiers

Primary DI / UDI-DI
06903095288381 EUDAMED
Basic UDI-DI
6903095SSPWGB1Z4HTDW EUDAMED
EMDN Code
P09070301 CERVICAL FIXATION SYSTEMS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

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

Sterile and Non Sterile Spinal System by Shandong Weigao Orthopaedic Device Company Limited. — Class IIb — MDR — listed in EUDAMED

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 edd8f4f1-48fc-4c5e-bb8b-f63b03c1c291 61 fields · synced Jun 19, 2026