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R-Rui RST063CA

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

R-Rui RST063CA is a Class II device made by Beijing Rongrui-Century Scie. & Tech. Co., Ltd., cleared under FDA 510(k) K103685 on 15 Jul 2011 and listed in FDA GUDID since 10 Apr 2024 (UDI-DI 16944290668056), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K103685

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16944290668056 UDI-DI Date10 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103685 Date15 Jul 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103685 decided 15 Jul 2011 Active
  • FDA GUDID UDI-DI 16944290668056 listed 10 Apr 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103685
  2. Listed FDA GUDID 16944290668056

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
R-Rui
Generic name
Pulse oximeter probe, reusable
Model / reference
RST063CA
Primary DI / UDI-DI
16944290668056
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter probe, reusable
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Pulse oximeter probe, reusable.

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

  • R-Rui RCT006

    Class II
  • R-Rui RSJ091DI

    Class II
  • R-Rui RCT018

    Class II
  • R-Rui RSA002DN

    Class II

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

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)