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
- [email protected]
- Phone
- 828 6243319 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2012-01-13 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-22 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2016-01-12 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2010-06-18 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2004-12-28 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2004-06-21 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2010-06-18 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2025-06-12 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2010-04-11 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-02-19 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2008-03-24 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2015-10-18 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2012-05-11 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2016-10-24 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-02-19 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2012-05-11 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2004-12-28 |
| Floss, Dental | JES | Class 1 | Dental | No | 2015-10-12 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2010-06-18 |
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