Data / Medical devices / Hong Kong / Pacific Care Limited / Pacificare Asia Limited

Pacific Care Limited / Pacificare Asia Limited: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance

Name: Pacific Care Limited / Pacificare Asia Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pacific Care Limited / Pacificare Asia Limited is registered with the FDA (registration 3004605493) in Hong Kong, Hong Kong. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 28, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3004605493
Address: Block 4, En Lai Industrial Estate, Dan Zhu Tou, Buji, Shenzhen / Flat 1, 1/F, Precision Manufacturing Centre, No.3 Dai Hei Street, Tai Po Ind. Est., N.T., Hong Kong, Hong Kong, -
Owner or operator: PACIFIC CARE LIMITED (9064332)
Roles: Contract manufacturer, Manufacturer
First device listed: June 21, 2004
Registered through: 2026
Brand names listed: Astek Innovations Ltd. / Medicom, Bluewater Dental Innovations / Shark Tray, Disposable Prophy Angle, Eye Shield, Face Shield, Henry Schein, Inc., IMPRESSION SYRINGE, MIRASUCTO and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Manufacturer	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Manufacturer	accessdata.fda.gov
Floss, Dental	JES	1	Manufacturer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer	accessdata.fda.gov
Instrument, Hand, Calculus Removal	ELA	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Contract manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Manufacturer	accessdata.fda.gov
Pick, Massaging	JET	1	Manufacturer	accessdata.fda.gov
Retainer, Matrix	JEP	1	Contract manufacturer	accessdata.fda.gov
Scraper, Tongue	LCN	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 28, 2025	K240950	Disposable Prophy Angle	EGS	Substantially Equivalent	Pacific Care Limited	accessdata.fda.gov

Compare with other makers

Updated May 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.