SHENZHEN YIMI LIFE TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3016171841

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
3016171841
FEI Number
3016171841
Entity Name
SHENZHEN YIMI LIFE TECHNOLOGY CO.,LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
302 Building C ,YouLiTong Industrial Plant ,No.56 Qingsong Road,Laokeng Community,Longtian Street , Pingshan, Shenzhen Guangdong 518118, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenzhen Yimi Life Technology Co.,Ltd (Owner Number: 10061585)
Owner / Operator Contact Address
302 Building C ,YouLiTong Industrial Plant ,No.56 Qingsong Road,Laokeng Community,Longtian Street , Pingshan, Shenzhen, CN-GD 518118, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

YM604 Pulse Oximeter YM201 Pulse Oximeter YM401 Pulse Oximeter YM113 Pulse Oximeter YM101 Pulse Oximeter YM103 Pulse Oximeter YM102 Pulse Oximeter YM501 Pulse Oximeter YM104 Pulse Oximeter YM112 Pulse Oximeter YM212 Pulse Oximeter YM403 Pulse Oximeter YM211 Pulse Oximeter YM301 Pulse Oximeter YM601 Pulse Oximeter YM314 Pulse Oximeter YM603 Pulse Oximeter YM302 Pulse Oximeter YM114 Pulse Oximeter YM502 Pulse Oximeter YM503 Pulse Oximeter YM202 Pulse Oximeter YM504 Pulse Oximeter YM402 Pulse Oximeter YM111 Pulse Oximeter YM602 Pulse Oximeter YM103 Pulse Oximeter YM201 Pulse Oximeter YM102 Pulse Oximeter YM101 Pulse Oximeter YM202 Pulse Oximeter YM301 Pulse Oximeter YM104 Pulse Oximeter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2024-12-12
DQA Oximeter Cardiovascular Class 2 870.2700 2019-10-31

Official Correspondent

Sand Peng

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Shenzhen Yimi Life Technology Co.,Ltd
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 3016171841. Last updated year: 2026. Please use registration number 3016171841 when referencing this establishment in official correspondence.
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