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Fingertip Pulse Oximeter

by Guangdong Biolight Meditech Co., Ltd

Ref M70CModel M70, M70A, M70B, M70C, M70D

Fingertip Pulse Oximeter (M70C) is a pulse oximeter (EU MDR Class IIa; FDA Class II; FDA product code DQA, Oximeter) made by Guangdong Biolight Meditech Co., Ltd, registered in EUDAMED on 22 Jan 2025 (Basic UDI-DI 69325623100113U), cleared under FDA 510(k) K151287 on 6 Jan 2016 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 06932562300363), 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) K151287

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 Number69325623100113U Basic UDI-DI 06932562300363UDI-DIDate22 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06932562300363 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151287 Date6 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69325623100113U registered 22 Jan 2025 Active
  • FDA 510(k) K151287 decided 6 Jan 2016 Active
  • FDA GUDID UDI-DI 06932562300363 listed 13 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151287
  2. Listed FDA GUDID 06932562300363
  3. Registered EUDAMED 69325623100113U

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  • Withdrawn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
Fingertip Pulse Oximeter EUDAMED
Fingertip Pluse Oximeter GUDID
Generic name
Pulse oximeter
Model / reference
M70, M70A, M70B, M70C, M70D
Primary DI / UDI-DI
06932562300363 EUDAMED
06932562310027 GUDID
Basic UDI-DI
69325623100113U
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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06932562300363
GUDID
06932562310027
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06932562300363; FDA GUDID lists 06932562310027), 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.

Manufacturer details

EUDAMED SRN
CN-MF-000006333
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Guangdong Biolight Meditech Co., Ltd

See all devices from Guangdong Biolight Meditech Co., Ltd →

Properties

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