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Apk I-A1902-SI135MU

by Apk Technology

Ref A5101-EC0

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
United StatesGUDID listing GUDID Number06946725521175 UDI-DI Date13 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69467255A-ECG-cableA6 Basic UDI-DI 06946725521175UDI-DIDate17 Nov 2025RegisteredStatusActive

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  • Withdrawn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
ECG Cables EUDAMED
Apk GUDID
Generic Name
Pulse oximeter probe, reusable
Device Name
ECG Lead wires
Model / Ref / Catalog
A5101-EC0 EUDAMED
I-A1902-SI135MU GUDID
A1902-SI135MU GUDID
Primary DI / UDI-DI
06946725521175
Basic UDI-DI
69467255A-ECG-cableA6
510(k) Number
FDA Product Code
DQA
EMDN Code
Z12030285 Vital signs monitoring instruments - consumables
GMDN Term
Pulse oximeter probe, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
A5101-EC0
GUDID
I-A1902-SI135MU
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K082846)

Show all (12)

Other devices from Apk Technology

See all devices from Apk Technology →

Properties

  • Serial Number
  • Expiration Date
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No