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Winch Kyphoplasty Balloon Catheter 11G 15mm

by G21 S.R.L.

Ref 900027

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08058964726766 Basic UDI-DI 08058964726766UDI-DIDate9 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08058964726766 UDI-DI Date13 Nov 2017ListedStatusListed 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 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Winch Kyphoplasty Balloon Catheter 11G 15mm EUDAMED
Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter GUDID
Generic Name
Inflatable bone tamp
Model / Ref / Catalog
900027
Primary DI / UDI-DI
08058964726766
Basic UDI-DI
B-08058964726766
510(k) Number
FDA Product Code
NDN, HRX
EMDN Code
K010301 Spinal percutaneous plastic devices with balloon
GMDN Term
Inflatable bone tamp
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3027, 888.1100
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000030085

Other devices from G21 S.R.L.

See all devices from G21 S.R.L. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Serial Number: No
  • Manufacturing Date: No