Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003908598

FEI Number

3003908598

Entity Name

VENTURE CORPORATION LIMITED

City/State/Country

Singapore North East, SG

Establishment Address

5006 Ang Mo Kio Avenue 5, #05-01/12, Singapore North East 569873, SG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Venture Corporation Limited (Owner Number: 10058887)

Owner / Operator Contact Address

5006 Ang Mo Kio Avenue 5, #05-01/12, Singapore, SG-02 569873, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163127

PMA Number

N/A

All Registered Proprietary Names

Bellavista 1000 US Evair Fisso, Respiration Arm light SmartLung Water Bottle Holder for Bellavista Ventilator Bellavista 1000 US

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-03-08
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2019-04-03
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2019-04-03
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2019-08-20
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2025-04-22
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2018-11-06

Official Correspondent

Thomas Lee

US Agent Details

Kay Tat Ng Business: VM Services, Inc. Email: kaytat.ng@venturemfg-usa.com Phone: (949) 6897339

Related Public Records

Same Entity

Venture Corporation 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
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
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Similar Registrations

Registration Number	Establishment Name	Location
3029922922	ORIGIN MEDICAL DEVICES HUNGARY KFT	Vac Pest, HU
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
2024500	COVIDIEN	CARLSBAD, CA, US
3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003908598. Last updated year: 2026. Please use registration number 3003908598 when referencing this establishment in official correspondence.