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Spinamic®

by VALUE & TRUST Co., Ltd. 10 variants

Ref 11-4600-1Model VSP-B11-00G, VSP-B11-01G, VSP-B11-02G, VSP-B11-03G, VSP-B11-04G, VSP-B11-05G, VSP-B11-06G, VSP-B11-07G, VSP-B11-08G, VSP-B11-09G

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88097669VSPB119S Basic UDI-DI 08809766910163UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809766910163 UDI-DI Date18 Mar 2026ListedStatusListed 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.

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  • Withdrawn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

Generic Name
Multiple spinal region orthosis
Device Name
Spinamic®
Model / Ref / Catalog
VSP-B11-00G, VSP-B11-01G, VSP-B11-02G, VSP-B11-03G, VSP-B11-04G, VSP-B11-05G, VSP-B11-06G, VSP-B11-07G, VSP-B11-08G, VSP-B11-09G, 11-4600-1, VNTC Spinamic VSP-B11-01G
Primary DI / UDI-DI
08809766910163
Basic UDI-DI
88097669VSPB119S
FDA Product Code
KTD
EMDN Code
Y060309 Thoracolumbosacral spine orthoses
GMDN Term
Multiple spinal region orthosis
Device Class
Class I
Regulation Number
890.3490
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
KR-MF-000026538
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Other devices from VALUE & TRUST Co., Ltd.

See all devices from VALUE & TRUST Co., Ltd. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Manufacturing Date: No