GREATCARE 4U SDN BHD

FDA Device Registration & Listing · Selangor Darul Ehsan, MY · Registration 3038285060

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
3038285060
FEI Number
3038285060
Entity Name
GREATCARE 4U SDN BHD
City/State/Country
Selangor Darul Ehsan, MY
Establishment Address
No15, Jalan Bestari 1/ku7, Taman Perindustrian Kapar Bestari, Kapar, Selangor Darul Ehsan 42200, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Greatcare 4u sdn bhd (Owner Number: 10093267)
Owner / Operator Contact Address
No15, Jalan Bestari 1/ku7, Taman Perindustrian Kapar Bestari, Kapar, Selangor Darul Ehsan, MY-NOTA 42200, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HEADREST COVER Disposable curved tip syringe, Disposable flow tip (pre-bent multipurpose dispensing tip) Disposable Irrigation Syringe Dental bibs Disposable saliva ejector Adult Diaper, Adult pants/pull-ups Couch paper roll Wet wipes Headrest cover

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRU Chair, Dental, Without Operative Unit Dental Class 1 872.6250 2025-05-22
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2025-04-21
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2025-04-21
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2025-04-21
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2025-04-21
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2025-04-21
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 2025-04-21
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2025-04-21
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2025-04-21

Official Correspondent

Yinbo Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Greatcare 4u sdn bhd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038285060. Last updated year: 2026. Please use registration number 3038285060 when referencing this establishment in official correspondence.
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