Non-sterile Spinal fixation System

by Beijing Libeier Bio-Engineering Institute Co., Ltd. 1,000+ variants

Ref B10000034Model ZZFEE-Ⅱ

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06942627271828 Basic UDI-DI 06942627271828UDI-DI	Date22 Sep 2026Registered	StatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device Name: Non-sterile Spinal fixation System
Model / Reference: ZZFEE-Ⅱ, B10000034

Primary DI / UDI-DI: 06942627271828
Basic UDI-DI: B-06942627271828
EMDN Code: P09070301 Cervical fixation systems

Device Class: Class III

Manufacturer details

EUDAMED SRN: CN-MF-000026344
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Beijing Libeier Bio-Engineering Institute Co., Ltd.

Locking Plate System

Class II

Properties

Implantable

Other properties (12)

Sterile: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No