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Chison

by CHISON Medical Technologies Co., Ltd. 17 variants

Ref XBit 90, SonoEye P2, CBit 4, SonoEye P1, SonoBook 8, SonoBook 7, SonoAir 30, SonoEye G2, CBit 6, QBit 3, SonoEye G5, D7L40L, SonoPort 8Model CBit 8, SonoBook 9, SonoAir 60, QBit 5, SonoEye P3, SonoEye P5

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 Date15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945121413459 UDI-DI Date24 Sep 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 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  • Withdrawn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
Linear probe GUDID
QBit Series Diagnostic Ultrasound System GUDID
SonoBook Series Diagnostic Ultrasound Systems GUDID
Digital Color Doppler Palm Ultrasound System GUDID
XBit Series Digital Color Doppler Ultrasound System GUDID
SonoAir Series Digital Color Doppler Ultrasound System GUDID
CBit Series Digital Color Doppler Ultrasound System GUDID
Generic Name
Foetal Doppler system probe
General-purpose ultrasound imaging system
Device Name
Diqital Color Doppler Ultrasound Svstem
Digital Color Doppler Ultrasound System
Model / Reference
XBit 90, SonoEye P2, CBit 8, CBit 4, D7L40L, QBit 3, SonoBook 7, SonoEye P1, SonoEye G2, SonoEye G5, SonoBook 8, SonoBook 9, SonoAir 30, CBit 6, SonoAir 60, QBit 5, SonoEye P3, SonoPort 8, SonoEye P5
Primary DI / UDI-DI
06945121413459, 06945121413077, 06945121413145, 06945121400145, 06945121414715, 06945121413305, 06945121413060, 06945121413671, 06945121413688, 06945121412681, 06945121411172, 06945121414777, 06945121412896, 06945121415873, 06945121415637
Basic UDI-DI
69451214XBitYH, 69451214P2CJ, 69451214CBitTW, 69451214P1CG, 69451214SonoBookRK, 69451214SonoAirZL, 69451214QBitWY, 69451214P3CL, 69451214SonoPortVG, 69451214P5CQ
Direct Marketing DI
06945121413077
06945121413145
06945121413060
06945121412681
06945121413305
06945121413671
06945121412896
06945121411172
06945121415873
06945121400145
06945121413688
510(k) Number
FDA Product Code
ITX, IYN, IYO
EMDN Code
Z11040104, Z11040106, Z11040103, Z1104018099
GMDN Term
Foetal Doppler system probe
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550, 892.1560
EU market of registration
Italy
Germany
Spain
Türkiye
Croatia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
No
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 YesEUDAMEDNoEUDAMEDGUDID
  • Reusable NoEUDAMEDYesEUDAMED
  • Measuring Function NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: 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