Skip to content

N/A Toco Transducer Watertight Button

by Wipro GE Healthcare Private Limited

Ref 2264HAX

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00130GS Basic UDI-DI 00840682104111UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682104111 UDI-DI Date24 Jun 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 23 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  • Withdrawn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
Toco Transducer Watertight Button
Generic Name
Foetal/maternal prenatal monitor
Device Name
TOCO Transducer
Model / Reference
2264HAX EUDAMED
TOCO TRANSDUCER WATERTIGHT BUTTON GUDID
Primary DI / UDI-DI
00840682104111
Basic UDI-DI
8406821BUG00130GS
Direct Marketing DI
00840682104111
510(k) Number
FDA Product Code
HEL, HFM
EMDN Code
Z1208010403 Transmitting units for cardiotocographic telemetry
GMDN Term
Foetal/maternal prenatal monitor
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.2660, 884.2720
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
2264HAX
GUDID
TOCO TRANSDUCER WATERTIGHT BUTTON
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Foetal/maternal prenatal monitor

Cleared under the same submission (K982651)

Other devices from Wipro GE Healthcare Private Limited

See all devices from Wipro GE Healthcare Private Limited →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No