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R-Rui RSA002DN

by Beijing Rongrui-Century Scie. & Tech. Co., Ltd.

Model RSA002DN

R-Rui RSA002DN is a device classified as Class IIb in the EU and Class II in the US made by Beijing Rongrui-Century Scie. & Tech. Co., Ltd., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-16944290665215), cleared under FDA 510(k) K103685 on 15 Jul 2011 and listed in FDA GUDID since 12 Nov 2022 (UDI-DI 16944290665215), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103685

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-16944290665215 Basic UDI-DI 16944290665215UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number16944290665215 UDI-DI Date12 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103685 Date15 Jul 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-16944290665215 registered 22 Oct 2026 Active
  • FDA 510(k) K103685 decided 15 Jul 2011 Active
  • FDA GUDID UDI-DI 16944290665215 listed 12 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103685
  2. Listed FDA GUDID 16944290665215
  3. Registered EUDAMED B-16944290665215

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
R-Rui
Generic name
Pulse oximeter probe, single-use
Device name
Pulse Oximeter Sensors
Model / reference
RSA002DN
Primary DI / UDI-DI
16944290665215
Basic UDI-DI
B-16944290665215
510(k) Number
FDA product code
DQA
EMDN code
C900301 Pulse oximeter sensors
GMDN term
Pulse oximeter probe, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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

Category: Pulse oximeter probe, single-use

Cleared under the same submission (K103685)

and 8 more cleared under K103685

Similar devices in this category

Other devices filed under PULSE OXIMETER SENSORS.

Other devices from Beijing Rongrui-Century Scie. & Tech. Co., Ltd.

  • R-Rui RCT006

    Class II

  • R-Rui RST063CA

    Class II

  • R-Rui RSJ091DI

    Class II

  • R-Rui RCT018

    Class II

See all devices from Beijing Rongrui-Century Scie. & Tech. Co., Ltd. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)