XINMED SDN. BHD.

FDA Device Registration & Listing · Senai Johor, MY · Registration 3036754877

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
3036754877
FEI Number
3036754877
Entity Name
XINMED SDN. BHD.
City/State/Country
Senai Johor, MY
Establishment Address
No. 6, Jalan SAC 2/5, Senai Airport City, Senai Johor 81400, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
XINMED SDN. BHD. (Owner Number: 10092716)
Owner / Operator Contact Address
No. 6, Jalan SAC 2/5, Senai Airport City, Senai, MY-01 81400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Disposable Anesthetic Masks S403S-01P0 S403-01P0 S403-490 S410S-910 S410-910

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2025-02-09
DQA Oximeter Cardiovascular Class 2 870.2700 2026-04-24
DQA Oximeter Cardiovascular Class 2 870.2700 2026-04-24
DQA Oximeter Cardiovascular Class 2 870.2700 2026-04-24
DQA Oximeter Cardiovascular Class 2 870.2700 2026-04-24

Official Correspondent

Joey Zhou

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

XINMED SDN. BHD.
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

Similar Registrations

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2028807 WESTMED, INC. TUCSON, AZ, US
1314417 SunMed Group Holdings, LLC Grand Rapids, MI, US
9613910 NARANG MEDICAL, LTD. New Delhi, IN
3005977696 MEDICAL DEVELOPMENTS INTERNATIONAL Scoresby Victoria, AU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036754877. Last updated year: 2026. Please use registration number 3036754877 when referencing this establishment in official correspondence.
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