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UPASS Rod

by Shandong Weigao Orthopaedic Device Company Limited. 3 variants

Ref 800005035, 800005070, 800005150, 800005130, 800005100, 800005030, 800005040, 800005120, 800005500, 800005075, 800005080, 800005110, 800005105Model WGB1Z-2, WGB1Z-7-23, WGB1Z-7-04

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6903095SPIWGB1Z2RD5S Basic UDI-DI Date10 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06939488337695 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
UPASS Rod EUDAMED
Connection Rod GUDID
Generic Name
Bone-screw internal spinal fixation system rod
Device Name
Sterile and Non Sterile Spinal System
Model / Reference
WGB1Z-2 EUDAMED
800005035 EUDAMED
800005070 EUDAMED
800005150 EUDAMED
WGB1Z-7-23 EUDAMED
800005130 EUDAMED
800005100 EUDAMED
800005030 EUDAMED
800005040 EUDAMED
800005120 EUDAMED
800005500 EUDAMED
800005075 EUDAMED
800005080 EUDAMED
800005110 EUDAMED
800005105 EUDAMED
WGB1Z-7-04 EUDAMED
8005110 GUDID
8005100 GUDID
Primary DI / UDI-DI
06939488337695, 06939488337763, 06939488399129, 06912547434566, 06939488337824, 06939488337688, 06939488337701, 06939488399099, 06939488337862, 06939488337770, 06939488337787, 06912547138204, 06912547138181, 06939488337848, 06939488337831, 06939488399105
Basic UDI-DI
6903095SPIWGB1Z2RD5S, 6903095SPIWGB1Z723RDUF, 6903095SPIWGB1Z704PRUU
510(k) Number
FDA Product Code
MNH, KWP, MNI
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070, 888.3050
EU market of registration
Lithuania
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
WGB1Z-2
800005035
800005070
800005150
WGB1Z-7-23
800005130
800005100
800005030
800005040
800005120
800005500
800005075
800005080
800005110
800005105
WGB1Z-7-04
GUDID
8005110
8005100
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000019785
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Shandong Weigao Orthopaedic Device Company Limited.

See all devices from Shandong Weigao Orthopaedic Device Company Limited. →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No