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Apk I-A0816-SP111PU

by APK Technology Co., Ltd.

Part of a family of 425 devices: see the family page

Ref A0816-TC03

Apk I-A0816-SP111PU is a device classified as Class I in the EU and Class II in the US made by APK Technology Co., Ltd., registered in EUDAMED on 20 Mar 2026 (Basic UDI-DI 69467255A-SPO2-cableKJ), cleared under FDA 510(k) K082846 on 3 Apr 2009 and listed in FDA GUDID since 13 Mar 2026 (UDI-DI 06946725520826), 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-cableKJ Basic UDI-DI 06946725520826UDI-DIDate20 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06946725520826 UDI-DI Date13 Mar 2026ListedStatusListed 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-cableKJ registered 20 Mar 2026 Active
  • FDA 510(k) K082846 decided 3 Apr 2009 Active
  • FDA GUDID UDI-DI 06946725520826 listed 13 Mar 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082846
  2. Listed FDA GUDID 06946725520826
  3. Registered EUDAMED 69467255A-SPO2-cableKJ

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  • Withdrawn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
SpO2 Extension Cable EUDAMED
Apk GUDID
Generic name
Pulse oximeter probe, reusable
Model / Ref / Catalog
A0816-TC03 EUDAMED
I-A0816-SP111PU GUDID
A0816-SP111PU GUDID
Primary DI / UDI-DI
06946725520826
Basic UDI-DI
69467255A-SPO2-cableKJ
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
A0816-TC03
GUDID
I-A0816-SP111PU
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.

Related devices

Cleared under the same submission (K082846)

and 8 more cleared under K082846

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS.

Other devices from APK Technology Co., Ltd.

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

Properties

  • Reusable
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)