INNOVATIF CEKAL SDN BHD

FDA Device Registration & Listing · Klang Selangor, MY · Registration 3012521761

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
3012521761
FEI Number
3012521761
Entity Name
INNOVATIF CEKAL SDN BHD
City/State/Country
Klang Selangor, MY
Establishment Address
No 35, 37, 15 & 17 Jalan Haji Adbul Karim 53, Kampung Jawa, Klang Selangor 41200, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Innovatif Cekal Sdn Bhd (Owner Number: 10061899)
Owner / Operator Contact Address
No 35 Jalan Haji Adbul Karim 53, Kampung Jawa, Klang, MY-10 41200, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Provox LaryClip TrachPhone

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2019-12-01
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2019-12-18

Official Correspondent

Yap Hin Loong Yap

US Agent Details

Jason Woehrle Business: Coloplast Corp. Email: usjawo@coloplast.com Phone: (612) 7302063

Related Public Records

Same Entity

Innovatif Cekal 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 3012521761. Last updated year: 2026. Please use registration number 3012521761 when referencing this establishment in official correspondence.
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