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Apk A0916-SW126PU

by APK Technology Co., Ltd.

Ref A0916-SW126PU

Apk A0916-SW126PU 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 10 Jun 2026 (Basic UDI-DI 69467255A-SPO2-RUV), cleared under FDA 510(k) K082846 on 3 Apr 2009 and listed in FDA GUDID since 13 Aug 2025 (UDI-DI 06946725535677), 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) K082846

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-RUV Basic UDI-DI 06946725535677UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06946725535677 UDI-DI Date13 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082846 Date3 Apr 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69467255A-SPO2-RUV registered 10 Jun 2026 Active
  • FDA 510(k) K082846 decided 3 Apr 2009 Active
  • FDA GUDID UDI-DI 06946725535677 listed 13 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082846
  2. Listed FDA GUDID 06946725535677
  3. Registered EUDAMED 69467255A-SPO2-RUV

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  • Withdrawn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
Reusable SpO2 Sensor EUDAMED
Apk GUDID
Generic name
Pulse Co-oximeter probe, reusable
Pulse oximeter probe, reusable
Model / Ref / Catalog
A0916-SW126PU, I-A0916-SW126PU
Primary DI / UDI-DI
06946725535677, 06946725515181
Basic UDI-DI
69467255A-SPO2-RUV
510(k) Number
FDA product code
DQA
EMDN code
C900301 Pulse oximeter sensors
GMDN term
Pulse Co-oximeter probe, reusable
Pulse oximeter probe, reusable
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 Co-oximeter probe, reusable

Cleared under the same submission (K082846)

and 8 more cleared under K082846

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

  • Serial number
  • Expiration date YesGUDIDNoGUDID
  • Manufacturing date
Other properties (22, all answered No)