SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY

FDA Device Registration & Listing · IPOH Perak, MY · Registration 3005191252

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
3005191252
FEI Number
3005191252
Entity Name
SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY
City/State/Country
IPOH Perak, MY
Establishment Address
2, JALAN KILANG TIGA, JELAPANG LIGHT IND. ESTATE, IPOH Perak 30100, MY
Establishment Type(s)
Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY (Owner Number: 9073700)
Owner / Operator Contact Address
2, JALAN KILANG TIGA, JELAPANG LIGHT IND. ESTATE, IPOH, MY-08 30100, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Kimono Kimono Kimono Kimono MicroThin with Aqua Lube Reality Ultra Lubricated

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2008-03-24
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2008-03-24
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2008-03-24
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2012-10-31

Official Correspondent

MEI LEE CHING

US Agent Details

Richard Hettenbach Business: Medqra, LLC Email: rickhettenbach@gmail.com Phone: (973) 2147468

Related Public Records

Same Entity

SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005191252. Last updated year: 2026. Please use registration number 3005191252 when referencing this establishment in official correspondence.
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