SANCTUARY HEALTH SDN BHD

FDA Device Registration & Listing · Chemor Perak, MY · Registration 3005497907

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
3005497907
FEI Number
3005497907
Entity Name
SANCTUARY HEALTH SDN BHD
City/State/Country
Chemor Perak, MY
Establishment Address
No. 16 Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, Chemor Perak 31200, MY
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Sanctuary Health Sdn Bhd (Owner Number: 9080281)
Owner / Operator Contact Address
No. 16 Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, Chemor, MY-08 31200, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sanctuary ComfiTract Latex- Free Cheek Retractor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJE Frame, Rubber Dam Dental Class 1 872.6300 2023-08-14
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2023-08-14
MSC Barrier, Std, Oral Sex Obstetrics/Gynecology Class 2 884.5300 2023-04-14
EIG Retractor, All Types Dental Class 1 872.4565 2025-12-09
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 2023-08-14
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2023-08-14
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2023-08-14
IOD Components, Exercise Physical Medicine Class 1 890.5350 2006-09-05

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Sanctuary Health Sdn Bhd
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 3005497907. Last updated year: 2026. Please use registration number 3005497907 when referencing this establishment in official correspondence.
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