Belun Technology Company Limited

FDA Device Registration & Listing · New Territories, HK · Registration 3016998644

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
3016998644
FEI Number
3016998644
Entity Name
Belun Technology Company Limited
City/State/Country
New Territories, HK
Establishment Address
Flat 47, 15/F., Block F, Wah Lok Industrial Centre, 31-41 Shan Mei Street, Fotan, New Territories 00000000, HK
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Belun Technology Company Limited (Owner Number: 10069714)
Owner / Operator Contact Address
Flat/RM 225B, 2/F, Building 1W, Phase One, Hong Kong Science Park Pak Shek Kok, New Territories, HK-NOTA 000000, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211407
PMA Number
N/A

All Registered Proprietary Names

Belun Sleep System Belun Ring

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2023-08-03
DQA Oximeter Cardiovascular Class 2 870.2700 2022-04-11

Official Correspondent

Lap Wai Lydia Leung

US Agent Details

GLORIA VERSE Email: gverse88@gmail.com Phone: (707) 7991525

Related Public Records

Same Entity

Belun Technology Company Limited
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
K082968 Apneicare, LLC APNEICARE CONNECTION CENTER/INTERNET ANALYSIS 2009-01-02
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2022 NOX MEDICAL Keldnaholt Reykjavik Iceland 2
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
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

Similar Registrations

Registration Number Establishment Name Location
3038274470 BRAINMATTERZ, INC McKinney, TX, US
3024891505 Acurable Limited London London, City of, GB
3009498109 MYCARDIO Denver, CO, US
3007616088 JIANGYIN SINBON ELECTRONICS CO LTD Jiangyin Jiangsu, CN
3026753386 ONERA B.V. Eindhoven Noord-Brabant, NL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016998644. Last updated year: 2026. Please use registration number 3016998644 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.