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Pulse Oximeter PC-60E

by Shenzhen Creative Industry Co., Ltd.

Ref PC-60EModel PC-60E、PC-60N、PC-60NW

Pulse Oximeter PC-60E 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 21 Apr 2026 (Basic UDI-DI 69419006FOximeter0102ZV), cleared under FDA 510(k) K063641 on 13 Jul 2007 and listed in FDA GUDID since 2 Nov 2016 (UDI-DI 06941900606470), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K063641

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69419006FOximeter0102ZV Basic UDI-DI 06941900606470UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06941900606470 UDI-DI Date2 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK063641 Date13 Jul 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69419006FOximeter0102ZV registered 21 Apr 2026 Active
  • FDA 510(k) K063641 decided 13 Jul 2007 Active
  • FDA GUDID UDI-DI 06941900606470 listed 2 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K063641
  2. Listed FDA GUDID 06941900606470
  3. Registered EUDAMED 69419006FOximeter0102ZV

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  • Withdrawn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-60E, PC-60E、PC-60N、PC-60NW
Primary DI / UDI-DI
06941900606470 EUDAMED
06941900603110 GUDID
Basic UDI-DI
69419006FOximeter0102ZV
Direct marketing DI
06941900606470
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
06941900606470
GUDID
06941900603110
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06941900606470; FDA GUDID lists 06941900603110), 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 (K063641)

and 8 more cleared under K063641

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)