FDA Registration Active 🇭🇰 Hong Kong

PACIFIC CARE LIMITED / PACIFICARE ASIA LIMITED

Reg #: 3004605493 · FEI: 3004605493 · Expires 2026
Products
19
Proprietary Names
14
Establishment Types
2
Classifications
19

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Registration Details

Registration Name
PACIFIC CARE LIMITED / PACIFICARE ASIA LIMITED
Registration Number
3004605493
FEI Number
3004605493
Status
Active
Expiry Year
2026
Initial Importer
No
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.
City
Hong Kong
Country
HK

Regulatory Submissions

510(k) Number
K240950

Owner / Operator

Firm Name
PACIFIC CARE LIMITED
Operator Number
9064332
Address
FLAT 1, 1/F, PRECISION MANUFACTURING CENTRE,, NO. 3, DAI HEI STREET, TAI PO INDUSTRIAL ESTATE,
City
N.T.
State
HK-NOTA
Postal Code
--
Country
HK
Correspondent
JONATHAN MANG

US Agent

Business Name
HAGER WORLDWIDE, INC.
Contact Name
Donna Pritchard
Address
441 19th St Se
City
Hickory
State
NC
ZIP
28602
Country
US
Phone
828 6243319 ext. 0

Products

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

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 Face Shield Practicon / IndiGreen Innovations IMPRESSION SYRINGE

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device