Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003361112

FEI Number

3003361112

Entity Name

UNIP PLASTIC INDUSTRIES SDN BHD

City/State/Country

CHERAS Selangor, MY

Establishment Address

LOT 3, JALAN CJ 1/6, KAWASAN PERUSAHAAN CHERAS JAYA,, JALAN BALAKONG, BATU 11,, CHERAS Selangor 43200, MY

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Unip Berhad (Owner Number: 9063902)

Owner / Operator Contact Address

Lot 3, Jalan CJ1/6, Kawasan Perusahaan, Cheras Jaya, Jalan Balakong, Batu 11,, Cheras,, MY-10 43200, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Suction Tip STRIP WAX Cheek Retractor : Zoom Retractors HANDPIECE, AIR-POWERED, ROOT CANAL IRRIGATION ZOOM 2 Goggles TONGUE SCRAPER DENTAL FLOSS THREADERS IMPRESSION TRAY GAUZE ZOOM CH GAUZE 12PK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-11-22
EKA	File, Margin Finishing, Operative	Dental	Class 1	872.4565	2016-09-02
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2004-06-02
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2020-12-06
NYL	Handpiece, Air-Powered, Root Canal Irrigation	Dental	Class 1	872.4200	2014-09-03
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2020-12-06
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2013-11-04
JES	Floss, Dental	Dental	Class 1	872.6390	2006-11-03
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2014-03-24
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2005-08-19

Official Correspondent

JIA YI WONG

US Agent Details

Bryan Tapocik Business: IPB Inc Email: rosanne@ipbinc.com Phone: (909) 8647477

Related Public Records

Same Entity

Unip Berhad

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003940985	SINORITA SENDIRIAN BERHAD	CHERAS Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003361112. Last updated year: 2026. Please use registration number 3003361112 when referencing this establishment in official correspondence.