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Chison

by CHISON Medical Technologies Co., Ltd. 17 variants

Ref XBit 80Model XBit 90

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 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/MDR EUDAMED Number69451214XBitYH Basic UDI-DI 06945121413787UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945121413787 UDI-DI Date10 Jul 2022ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Chison EUDAMED
XBit Series Digital Color Doppler Ultrasound System GUDID
Generic Name
General-purpose ultrasound imaging system
Device Name
Diqital Color Doppler Ultrasound Svstem
Model / Reference
XBit 90, XBit 80
Primary DI / UDI-DI
06945121413787
Basic UDI-DI
69451214XBitYH
510(k) Number
FDA Product Code
IYO, IYN
EMDN Code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560, 892.1550
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000021605
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from CHISON Medical Technologies Co., Ltd.

See all devices from CHISON Medical Technologies Co., Ltd. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Lot / Batch Number: No
  • Expiration Date: No