The Hygenic Corporation

FDA Device Registration & Listing · Batu Gajah Perak, MY · Registration 9681338

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
9681338
FEI Number
3003123739
Entity Name
The Hygenic Corporation
City/State/Country
Batu Gajah Perak, MY
Establishment Address
Plot 6 Bemban Industrial Park, Batu Gajah Perak 31000, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
The Hygenic Company, LLC (Owner Number: 1519375)
Owner / Operator Contact Address
1245 Home Ave, Akron, OH 44310, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BD Stretch Tourniquet Strap Hygenic Hysynal Tourniquet Strap Underwrap Tape EcoFlex Stretch Tape Self-Stick Tape Bulk HYSNAL Accessory Leg Strap Flexi Dam Non-Latex Framed Flexi Dam Non-Latex NON-LATEX DENTAL DAM Rubber Dam Elasti-Dam Fiesta Dental Dam HYGENIC DENTAL DAM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 1995-09-05
FQM Bandage, Elastic General Hospital Class 1 880.5075 1996-06-21
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 1998-02-27
EIE Dam, Rubber Dental Class 1 872.6300 1977-11-15

Official Correspondent

Melanie Leibowitz

US Agent Details

Melanie Leibowitz Email: melanie.leibowitz@performancehealth.com Phone: (331) 6889688

Related Public Records

Same Entity

The Hygenic Company, 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
1519375 THE HYGENIC COMPANY, LLC Akron, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K040797 Britesmile, Inc. BRITESMILE MASKING CREAM 2004-04-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681338. Last updated year: 2026. Please use registration number 9681338 when referencing this establishment in official correspondence.
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