SUNMED AP, LTD., WAREHOUSE NO. 2

FDA Device Registration & Listing · ZHUHAI Guangdong, CN · Registration 3044994756

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
3044994756
FEI Number
3044994756
Entity Name
SUNMED AP, LTD., WAREHOUSE NO. 2
City/State/Country
ZHUHAI Guangdong, CN
Establishment Address
1ST FLOOR WAREHOUSE NO. 2, SF EXPRESS SUPPLY CHAIN COMPREHENSIVE LOGISTICS PARK NO. 320 GANLI RD. DOUMEN DISTRICT, ZHUHAI Guangdong CN 519100, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
VENTLAB, LLC (Owner Number: 2246980)
Owner / Operator Contact Address
2710 Northridge Dr. NW, Suite A, --, Grand Rapids, MI 49544, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CombiGuard Soft Seal Mask GE Healthcare Vent Mask BreathTech Soft-Aire Medline Vent Mask II Provider Enterprise Medline Ventlab BreathTech NEOCHECK Blood Pressure Cuff Zefron BP Cuffs ComfortCheck Blood Pressure Cuff Colormetric etCO2 detector (MaxCap) Bite Block Block BreathTech Aerial Alliance Tech Medical Breathrite Spacer DuraCheck Blood Pressure Cuffs SunMed SafeT T Piece Resuscitator Oxygen Tubing Ventlab Pressure Tubing and Accessories End Tidal CO2 Cannula MedLine Cannula Infu-Surg Bag Pressure Infusion Bag Infusor, Disposable, INFUSEIT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2016-09-14
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2010-12-20
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2007-12-17
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2006-08-03
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2023-08-08
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2024-08-27
JXL Block, Bite Neurology Class 2 882.5070 2023-02-17
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2007-12-17
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2024-09-06
BTL Ventilator, Emergency, Powered (Resuscitator) Anesthesiology Class 2 868.5925 2019-01-07
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 1992-11-19
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-07-27
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2001-09-26

Official Correspondent

Rob Yamashita

US Agent Details

Rob Yamashita Business: AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005998497 SUNMED AP, LTD. ZHUHAI Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K831001 Frontier Products UNICUFF-BLOOD PRESSURE CUFF 1983-07-28
K253089 Shenzhen Best Electronics Co., Ltd. NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) 2026-02-13
K972301 Rudolf Riester GmbH & Co. KG BIG BEN SQUARE, BIG BEN ROUND 1997-09-17
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

Registration Number Establishment Name Location
3012070313 Nupur Technologies Buffalo, NY, US
3027473313 ZHEJIANG HOPE PHARMA LTD Wenzhou Zhejiang, CN
2084346 MARINA MEDICAL INSTRUMENTS, INC. Davie, FL, US
1416980 BAXTER HEALTHCARE CORPORATION ROUND LAKE, IL, US
3016734024 UNIVERSALPROMO INC. Maple Grove, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044994756. Last updated year: 2026. Please use registration number 3044994756 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.