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Apk A1411-SI03C

by APK Technology Co., Ltd.

Ref A1411-SI03C

Apk A1411-SI03C is a device classified as Class IIb in the EU and Class II in the US made by APK Technology Co., Ltd., registered in EUDAMED on 9 Jun 2026 (Basic UDI-DI 69467255A-SPO2-DTZ), cleared under FDA 510(k) K172981 on 8 Jun 2018 and listed in FDA GUDID since 22 Sep 2025 (UDI-DI 06946725504260), active as of 12 Nov 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

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172981

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69467255A-SPO2-DTZ Basic UDI-DI 06946725504260UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06946725504260 UDI-DI Date22 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172981 Date8 Jun 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69467255A-SPO2-DTZ registered 9 Jun 2026 Active
  • FDA 510(k) K172981 decided 8 Jun 2018 Active
  • FDA GUDID UDI-DI 06946725504260 listed 22 Sep 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172981
  2. Listed FDA GUDID 06946725504260
  3. Registered EUDAMED 69467255A-SPO2-DTZ

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  • Withdrawn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
Disposable SpO2 sensor EUDAMED
Apk GUDID
Generic name
Pulse oximeter probe, single-use
Model / reference
A1411-SI03C
Primary DI / UDI-DI
06946725504260
Basic UDI-DI
69467255A-SPO2-DTZ
510(k) Number
FDA product code
DQA
EMDN code
C900301 Pulse oximeter sensors
GMDN term
Pulse oximeter probe, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Pulse oximeter probe, single-use

Cleared under the same submission (K172981)

and 8 more cleared under K172981

Similar devices in this category

Other devices filed under PULSE OXIMETER SENSORS.

Other devices from APK Technology Co., Ltd.

See all devices from APK Technology Co., Ltd. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)