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Pulse Oximeter PC-60FW

by Shenzhen Creative Industry Co., Ltd.

Ref PC-60FWModel PC-60B1、POD-3、PC-60F、PC-60FW

Pulse Oximeter PC-60FW is a pulse oximeter (EU MDR Class IIa; FDA Class II; FDA product code DQA, Oximeter) made by Shenzhen Creative Industry Co., Ltd., registered in EUDAMED on 17 Jul 2025 (Basic UDI-DI 69419006FOximeter0101ZT), cleared under FDA 510(k) K120502 on 7 Dec 2012 and listed in FDA GUDID since 3 Aug 2023 (UDI-DI 06941900606623), active as of 25 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

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120502

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69419006FOximeter0101ZT Basic UDI-DI 06941900606623UDI-DIDate17 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06941900606623 UDI-DI Date3 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK120502 Date7 Dec 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69419006FOximeter0101ZT registered 17 Jul 2025 Active
  • FDA 510(k) K120502 decided 7 Dec 2012 Active
  • FDA GUDID UDI-DI 06941900606623 listed 3 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120502
  2. Listed FDA GUDID 06941900606623
  3. Registered EUDAMED 69419006FOximeter0101ZT

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  • Withdrawn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
Pulse Oximeter
Generic name
Pulse oximeter
Device name
Fingertip Oximeter
Model / reference
PC-60FW, PC-60B1、POD-3、PC-60F、PC-60FW
Primary DI / UDI-DI
06941900606623 EUDAMED
06941900604414 GUDID
Basic UDI-DI
69419006FOximeter0101ZT
Direct marketing DI
06941900606623
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Pulse oximeter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06941900606623
GUDID
06941900604414
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06941900606623; FDA GUDID lists 06941900604414), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

From the manufacturer

Manufacturer's product page: Pulse Oximeters

Related devices

Category: Pulse oximeter

Cleared under the same submission (K120502)

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Shenzhen Creative Industry Co., Ltd.

See all devices from Shenzhen Creative Industry Co., Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)