SELIA-TEK MEDICAL SDN BHD

FDA Device Registration & Listing · Petaling Jaya Selangor, MY · Registration 3008247695

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
3008247695
FEI Number
3008247695
Entity Name
SELIA-TEK MEDICAL SDN BHD
City/State/Country
Petaling Jaya Selangor, MY
Establishment Address
No.18, Jalan Teknologi 3/5, Taman Sains Selangor, Kota Damansara, Petaling Jaya Selangor 47810, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Selia-Tek Medical Sdn Bhd (Owner Number: 10031345)
Owner / Operator Contact Address
No. 2-12, Jalan Marikh U5/175, Bandar Pinggiran Subang, Shah Alam, MY-10 40150, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Qlicksmart BladeNeedleSYSTEM; BladeNeedleSYSTEM; Qlicksmart Sterile Blade Remover QLICKSMART CASSETTE 3in1; BladeCASSETTE; Qlicksmart BladeCASSETTE; Qlicksmart Sterile Blade Remover; QLICKSMART BladeSINGLE; BladeCARTRIDGE-1; BladeSINGLE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2013-06-02
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2011-04-24

Official Correspondent

Mohd Khairi Mat Isa

US Agent Details

David Baetens Email: david@oakmedproducts.com Phone: (248) 7620900

Related Public Records

Same Entity

Selia-Tek Medical 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-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

Registration Number Establishment Name Location
3027516563 STAR SPORTS MEDICINE CO., LTD. Beijing, CN
3016678045 Schneider ASR B.V. Rotterdam-Albrandswaard Zuid-Holland, NL
3015131017 FIELD ORTHOPAEDICS Teneriffe Queensland, AU
9610612 AESCULAP AG TUTTLINGEN, DONAU Baden-Wurttemberg, DE
3008392711 ANQING KANGMINGNA PACKAGING CO.,LTD Anqing Anhui, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008247695. Last updated year: 2026. Please use registration number 3008247695 when referencing this establishment in official correspondence.
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