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XPLUS 35 Series XPLUS 35FD

by Gemss Healthcare Co., Ltd.

Ref XCO-CL-003Model XPLUS 35, XPLUS 35FD

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880009870fluWA Basic UDI-DI 08800098700156UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800098700156 UDI-DI Date16 Jan 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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
Xplus 35FD EUDAMED
XPLUS 35 Series GUDID
Generic Name
Mobile general-purpose fluoroscopic x-ray system, digital
Model / Reference
XPLUS 35, XPLUS 35FD, XCO-CL-003
Primary DI / UDI-DI
08800098700156
Basic UDI-DI
880009870fluWA
510(k) Number
FDA Product Code
OWB
EMDN Code
Z11039017 Mobile radioscopic units
GMDN Term
Mobile general-purpose fluoroscopic x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1650
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
XPLUS 35, XPLUS 35FD
XCO-CL-003
GUDID
XPLUS 35FD
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K233200)

Other devices from Gemss Healthcare Co., Ltd.

Properties

  • Reusable
  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No