Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004605493

FEI Number

3004605493

Entity Name

PACIFIC CARE LIMITED / PACIFICARE ASIA LIMITED

City/State/Country

Hong Kong, HK

Establishment 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 -, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PACIFIC CARE LIMITED (Owner Number: 9064332)

Owner / Operator Contact Address

FLAT 1, 1/F, PRECISION MANUFACTURING CENTRE,, NO. 3, DAI HEI STREET, TAI PO INDUSTRIAL ESTATE,, N.T., HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Astek Innovations Ltd. / Medicom Non-surgical isolation gown United Exchange Corp Bluewater Dental Innovations / Shark Tray MIRASUCTO Sunstar Butler, Inc. Disposable Prophy Angle Henry Schein, Inc. Eye Shield PREMIUM SCALER, SONIC SCALER Pearson Dental Supply, Inc Astek Innovations Ltd. / Medicom

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2012-01-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-22
JET	Pick, Massaging	Dental	Class 1	872.6650	2016-01-12
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2010-06-18
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2004-12-28
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2004-06-21
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2010-06-18
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2025-06-12
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2010-04-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-02-19
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2008-03-24
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2015-10-18
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2012-05-11
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2016-10-24

Official Correspondent

JONATHAN MANG

US Agent Details

Donna Pritchard Business: HAGER WORLDWIDE, INC. Email: d.pritchard@hagerworldwide.com Phone: (828) 6243319

Related Public Records

Same Entity

PACIFIC CARE LIMITED

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
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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8043622	RICHBOLT ENTERPRISES	SIALKOT Punjab, PK
9611367	HELMUT ZEPF MEDIZINTECHNIK GMBH	SEITINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004605493. Last updated year: 2026. Please use registration number 3004605493 when referencing this establishment in official correspondence.