BEIJING AEONMED CO., LTD.

FDA Device Registration & Listing · Sanhe Hebei, CN · Registration 3007238566

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
3007238566
FEI Number
3007238566
Entity Name
BEIJING AEONMED CO., LTD.
City/State/Country
Sanhe Hebei, CN
Establishment Address
No.10 Chaobai Street, Yingbin Road West, Yanjiao Development Zone, Sanhe Hebei 065201, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Beijing Aeomed Co., Ltd. (Owner Number: 10028410)
Owner / Operator Contact Address
Room 405, Basement 1 to 4th Floor of 901 Unit, Building 9, No.26 Outer Ring West Road,, Fengtai District, Beijing, CN-BJ 100070, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

C4500 Medical Air Compressor T3600 Operating Table L2700 Surgical Light System Gas-machine, anesthesia V8800 Critical Care Ventilator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2013-02-18
GDC Table, Operating-Room, Electrical General, Plastic Surgery Class 1 878.4960 2011-07-04
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2013-02-18
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2014-06-20
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2013-07-16
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2013-07-16
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2013-07-16
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-07-16

Official Correspondent

RA Heyer

US Agent Details

Kurtis Montegna Business: Oricare Email: kmontegna.km@gmail.com Phone: (530) 2275344

Related Public Records

Same Entity

Beijing Aeomed 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
K900686 Medical Industries America, Inc. MAXI COMPRESSORS 1990-04-26
K780666 Castle Co. DAYSTAR SELECTRA & SELECTRA/ORBITER 1978-04-27
K252746 Drägerwerk AG Co. Kgaa Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) 2026-05-21
K051895 Datex-Ohmeda, Inc. GE DATEX-OHMEDA ENGSTROM CARESTATION 2005-09-27
K082966 Covidien, Formerly Nellcor Puritan Bennett, Inc. PB 540 VENTILATOR 2008-10-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007238566. Last updated year: 2026. Please use registration number 3007238566 when referencing this establishment in official correspondence.
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