Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011538588

FEI Number

3011538588

Entity Name

Haemonetics Malaysia Sdn Bhd

City/State/Country

Penang Pulau Pinang, MY

Establishment Address

PMT 727, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan,14100 Simpang Ampat, Penang Pulau Pinang ., MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Haemonetics Corporation (Owner Number: 1219343)

Owner / Operator Contact Address

125 Summer St, Boston, MA 02110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK220798

PMA Number

N/A

All Registered Proprietary Names

PCS2, PCS 300, NexSys PCS NexSys PCS, Express Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-11-12
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2023-06-21

Official Correspondent

Julie Ryan

US Agent Details

Julie A Ryan Business: HAEMONETICS CORPORATION Email: julie.ryan@haemonetics.com Phone: (781) 6900575

Related Public Records

Same Entity

Haemonetics Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011773324	Haemonetics Corporation	Salt Lake City, UT, US
9617787	Haemonetics Mexico Manufacturing S. de R.L. de C.V.	TIJUANA, B.C. Mexico, MX
3019849102	Haemonetics Corporation	Clinton, PA, US
1219343	HAEMONETICS CORPORATION	Boston, MA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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3032902763	BGS US LLC	Imperial, PA, US
3004601221	Comar	Rancho Cucamonga, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011538588. Last updated year: 2026. Please use registration number 3011538588 when referencing this establishment in official correspondence.