Firstar Healthcare Company Limited (Guangzhou)
Manufacturer and brand owner in Guangzhou, Guangdong, China. 57 device types, 12 products catalogued, 1 clearance.
Firstar Healthcare Company Limited (Guangzhou) is a contract manufacturer holding a current FDA establishment registration. The registration covers Crutch, Forceps and 55 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2004.
57device types registered with the FDA
12products catalogued under its own name
1510(k) clearance
Registration
| Registered name | FIRSTAR HEALTHCARE Company Limited (Guangzhou) |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003887292 |
| FEI number | 3003887292 |
| DUNS | 529576331 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广州市富泓医疗用品有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Rm.901, Hq Bldg 2, Tian An High-Tech Ecological Park, Panyu |
| Postal code | 511475 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | Toilet Safety Rail, Commode Chair, Shower Chair | 2026 | 193 |
| Adhesive Backed Thermal Skin Patches | Class 1 | Pain Relief Patch | 2024 | 48 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Firstar Reservoir KIT, Wound Drainage Reservoir | 2004 | 58 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Firstar Swab Stick | 2006 | 186 |
| Bandage, Cast | Class 1 | Firstar Triangle Bandage, Cast Bandage, Plaster of Paris Bandage | 2006 | 81 |
| Bandage, Elastic | Class 1 | Firstar | 2004 | 280 |
| Basin, Emesis | Class 1 | Vomit Bag, Emesis Bag | 2022 | 65 |
| Cannula, Nasal, Oxygen | Class 1 | plastic tubing | 2016 | 97 |
| Continuous Measurement Thermometer | Class 2 | Clinical Electronic Thermometer | 2014 | 115 |
| Cover, Cast | Class 1 | Cast and Bandage Protector | 2014 | 31 |
| Cover, Shoe, Operating-Room | Class 1 | Disposable shoe cover | 2020 | 176 |
| Crimper, Pin | Class 1 | Safety Pin, Pins | 2007 | 7 |
| Crutch | Class 1 | Walking Stick | 2026 | 112 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue Depressor | 2006 | 100 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Prep Pad, BZKAntiseptic Swab/Antiseptic Cleaning wipes-SlingFree | 2015 | 197 |
| Dispenser, Liquid Medication | Class 1 | Medicine cup | 2024 | 86 |
| Dispenser, Solid Medication | Class 1 | Pill Box | 2023 | 68 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Burn dressing, Burn gel | 2025 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | first aid bandage, FIRSTAR first aid dressing, hydrocolloid | 2009 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Foam dressing | 2023 | 183 |
| Driver, Surgical, Pin | Class 1 | Safety Pin, Sterile | 2022 | 12 |
| Extractor, Vein | Class 1 | Venimex pump | 2014 | 3 |
| Fiber, Medical, Absorbent | Class 1 | Abdominal combine pads | 2020 | 172 |
| First Aid Kit With Drug | Class N | First Aid Kit with Drug | 2017 | 57 |
| First Aid Kit Without Drug | Class 1 | Firstar First AID Kits, Empty First AID BOX | 2009 | 132 |
| Forceps | Class 1 | Tweezers | 2005 | 99 |
| Garment, Protective, For Incontinence | Class 1 | Blanket | 2007 | 181 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Roll, Gauze Bandage, Firstar | 2004 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Wound packing gauze | 2009 | 67 |
| Iodine (Tincture) | Class 1 | Iodine Prep Pad | 2024 | 5 |
| Marker, Skin | Class 1 | Skin Marker or Marking Pen or Skin Marker Pen | 2026 | 55 |
| Mask, Gas, Anesthetic | Class 1 | Triseal Mask/anaesthetic mask | 2005 | 71 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | CPR Mask | 2021 | 72 |
| Mouthpiece, Breathing | Class 1 | Firstar Mouth TO Mouth Shield | 2004 | 67 |
| Nasal Spray, Ent Delivery | Class 1 | Inhaler | 2019 | 23 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
| Orthosis, Cervical | Class 1 | Orthosis, cervical, Cervical Collar | 2014 | 114 |
| Pack, Hot Or Cold, Disposable | Class 1 | Instant Cold PAC | 2006 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | Reusable Hot and Cold Pack | 2006 | 178 |
| Pad, Eye | Class 1 | Eye Pad | 2005 | 100 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | Class 1 | Firstar Underpad | 2005 | 29 |
| Pill Crusher/Cutter | Class 1 | Pill Cutter | 2019 | 41 |
| Polymer Patient Examination Glove | Class 1 | Patient Examination Gloves | 2024 | 83 |
| Protector, Skin Pressure | Class 1 | Footcare | 2006 | 101 |
| Respirator, Surgical | Class 2 | Particulate Respirator | 2020 | 118 |
| Scissors, Medical, Disposable | Class 1 | Trauma shears, Firstar | 2005 | 36 |
| Shield, Protective, Personnel | Class 1 | Isolation Face Shield, Isolation Face Mask, Medical Face Shield, Medical Shield, Face Shield | 2020 | 78 |
| Sling, Arm | Class 1 | Arm Sling | 2022 | 126 |
| Spill Kit | Class 1 | Spill Kit | 2020 | 2 |
| Splint, Traction | Class 1 | Medical External Fixation Brace, Medical Splint | 2025 | 27 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | Medical Support | 2023 | 76 |
| Stretcher, Hand-Carried | Class 1 | stretcher | 2005 | 51 |
| Syringe, Irrigating (Non Dental) | Class 1 | Ear Syringe | 2025 | 110 |
| Tape And Bandage, Adhesive | Class 1 | Inject-safe Bandage, Firstar Strips, Band aid, Adhesive Bandage | 2004 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2005 | 124 |
| Valve, Non-Rebreathing | Class 2 | CPR Face Shield, Pocket Mask, CPR Mask, E Mask | 2014 | 19 |
| Walker, Mechanical | Class 1 | Walker | 2026 | 183 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| BrightCare | OHO | 7 |
| Outerbanks | OHO | 2 |
| E+R | CBP | 2 |
| Xpect | CBP | 1 |
| Firstar | CBP | 1 |
| Seal Quik | CBP | 1 |
Clearances
1 clearance names Firstar Healthcare Company Limited (Guangzhou) as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K192285 | 2020-11-25 | CBP | Traditional | This company |
| K203593 | 2021-03-19 | LZA | Traditional | Guangdong Kingfa Medical SCI.&Tech. Co., Ltd. |
| K083418 | 2010-07-22 | CBP | Traditional | Firstar Healthcare Co., Ltd. |
| K051699 | 2006-02-06 | FLL | Traditional | Sejoy Electronics & Instruments Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | First Aid Kits, First Aid Boxes, Wound plasters, Emergency blankets, CPR masks |
| Certifications | ISO certified, CE marked, DIN certification, FDA registered |
| Export markets | Americas, Europe, Australia, Middle East |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.