Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003528228

FEI Number

3003528228

Entity Name

HOSPITECH MANUFACTURING SERVICES SDN BHD

City/State/Country

Shah Alam Selangor, MY

Establishment Address

Sub Lot 1, Lot 6536, Batu 6, Jalan Bukit Kemuning, Seksyen 34, Shah Alam Selangor 40460, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hospitech Manufacturing Services Sdn Bhd (Owner Number: 10095153)

Owner / Operator Contact Address

Sub Lot 1, Lot 6536, Batu 6, Jalan Bukit Kemuning, Seksyen 34, Shah Alam, MY-10 40460, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DRAINAGE BOTTLE SURGICAL CONNECTING TUBE BLOOD TAKING SET URIDROP OXYGEN NASAL CANNULA CLOSED SUCTION CATHETER, MUCUS EXTRACTOR HIGH CONCENTRATION MASK STERIPAD DRESSING PACK, ETT SET ALCOHOL SWAB NEEDLE HOLDER OXYGEN MASK, TRACHEOSTOMY MASK SWABBING SET AMNIOTIC HOOK RENAL DRESSING SET, INJECTION SET, HAEMO DRESSING PACK - 1F (6G6GB), BASIC DRESSING SET-BDS INTUBATION STYLET MALE & FEMALE URINAL, UNISEX URINAL PRE PACK OBSTETRICS TUBING WITH Y-CONNECTOR SUTURE REMOVAL SET UMBILICAL CORD CLAMP DISPOSABLE ANAESTHETIC BREATHING CIRCUITS URINE COLLECTOR SUCTION SET, SUCTION CATHETER, SUCTION YANKAUER VENTURI MASK HAEMO DRESSING PACK FEMALE CATHETER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2026-01-29
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-01-29
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2026-01-29
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2026-01-29
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2026-01-29
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2026-01-29
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2026-01-29
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-01-29
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2026-01-29
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2026-01-29
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2026-01-29
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2026-01-29
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2026-01-29
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-01-29
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2026-01-29
FNP	Urinal	General Hospital	Class 1	880.6730	2026-01-29
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-01-29
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2026-01-29
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2026-01-29
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2026-01-29
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2026-01-29
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2026-01-29
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2026-01-29
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2026-01-29
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2026-01-29

Official Correspondent

Desmond Wong

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hospitech Manufacturing Services Sdn Bhd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003528228. Last updated year: 2026. Please use registration number 3003528228 when referencing this establishment in official correspondence.