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ECG D-SUB2 B 3.5/3.1 x14 IEC

by Schiller AG

Part of a family of 9 devices: see the family page

Ref 2.400335Model ECG D-SUB2- 10-wire patient cable IEC, clip type, 4.6/4.25 m

ECG D-SUB2 B 3.5/3.1 x14 IEC (2.400335) is a device classified as Class I in the EU and Class II in the US made by Schiller AG, registered in EUDAMED on 11 May 2026 (Basic UDI-DI 76133650000000204Y), cleared under FDA 510(k) K183425 on 2 Mar 2020 and listed in FDA GUDID since 26 May 2026 (UDI-DI 07613365004212), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K183425; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183425

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07613365004212 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76133650000000204Y Basic UDI-DI 07613365004212UDI-DIDate11 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183425 Date2 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76133650000000204Y registered 11 May 2026 Active
  • FDA 510(k) K183425 decided 2 Mar 2020 Active
  • FDA GUDID UDI-DI 07613365004212 listed 26 May 2026 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2734-2024 FDA Class II initiated 24 Jul 2024 on shared 510(k) K183425

    Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K183425
  2. Recall initiated FDA recalls Z-2734-2024
  3. Registered EUDAMED 76133650000000204Y
  4. Listed FDA GUDID 07613365004212

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ECG D-SUB2 B 3.5/3.1 x14 IEC EUDAMED
Schiller GUDID
Generic name
Electrocardiographic lead set, reusable
Device name
ECG D-SUB2 C 4.6/4.25 x10 IEC
Model / Ref / Catalog
ECG D-SUB2- 10-wire patient cable IEC, clip type, 4.6/4.25 m, 2.400335, ECG D-SUB2 B 3.5/3.1 x14 IEC
Primary DI / UDI-DI
07613365004212
Basic UDI-DI
76133650000000204Y
Direct marketing DI
07613365004212
510(k) Number
FDA product code
DSA
EMDN code
Z12050380 Electrocardiographs - hardware accessories
GMDN term
Electrocardiographic lead set, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2900
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ECG D-SUB2- 10-wire patient cable IEC, clip type, 4.6/4.25 m
2.400335
GUDID
ECG D-SUB2 B 3.5/3.1 x14 IEC
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CH-MF-000012722
Authorised representative
SCHILLER Medizintechnik GmbH DE-AR-000006934

Related devices

Category: Electrocardiographic lead set, reusable

Similar devices in this category

Other devices filed under ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES.

Other devices from Schiller AG

See all devices from Schiller AG →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)