ANRIWELL

FDA Device Registration & Listing · Irvine, CA, US · Registration 3043513123

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043513123
FEI Number
3043513123
Entity Name
ANRIWELL
City/State/Country
Irvine, CA, US
Establishment Address
2062 Business Center Dr Ste 125, Irvine, CA 92612, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Anriwell (Owner Number: 10095154)
Owner / Operator Contact Address
2062 BUSINESS CENTER DRIVE, STE 125, Irvine, CA 92604, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K160019
PMA Number
N/A

All Registered Proprietary Names

AW-401 Anriwell Breeze AW-401 Anriwell Breeze (OTC) Anriwell Tempie AW-201 Anriwell Gluco AW-501 AW-301 Anriwell Pressia

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2026-01-29
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2026-04-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2026-01-29
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2026-03-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-03-19

Official Correspondent

YINING CHEN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Anriwell
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043513123. Last updated year: 2026. Please use registration number 3043513123 when referencing this establishment in official correspondence.
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