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Pulse Oximeter S13B

by Shenzhen Viatom Technology Co., Ltd.

Pulse Oximeter S13B is a pulse oximeter (FDA Class II; FDA product code OCH, Oximeter, Infrared, Sporting, Aviation) made by Shenzhen Viatom Technology Co., Ltd., registered in EUDAMED and listed in FDA GUDID since 23 Dec 2024 (UDI-DI 06934440102854), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06934440102854 UDI-DI Date23 Dec 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 06934440102854 listed 23 Dec 2024 Listed

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Pulse Oximeter
Generic name
Pulse oximeter
Model / reference
S13B
Primary DI / UDI-DI
06934440102854
FDA product code
OCH
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Pulse oximeter

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Other devices filed under Pulse oximeter.

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Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)