Data / Medical devices / China / FIRSTAR HEALTHCARE Company Limited (Guangzhou)
FIRSTAR HEALTHCARE Company Limited (Guangzhou): FDA-registered device maker in Guangzhou Guangdong, China, 4 510(k) clearances
FIRSTAR HEALTHCARE Company Limited (Guangzhou) is registered with the FDA (registration 3003887292) in Guangzhou Guangdong, China. It lists 57 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 19, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003887292
- Address
- Rm.901, Hq Bldg 2, Tian An High-Tech Ecological Park, Panyu, Guangzhou Guangdong, China, 511475
- Owner or operator
- FIRSTAR HEALTHCARE Company Limited (Guangzhou) (9062173)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- March 23, 2004
- Registered through
- 2026
- Brand names listed
- ADHESIVE BANDAGE, Abdominal combine pads, Alcohol Prep Pad, Arm Sling, BLANKET, BZKAntiseptic Swab/Antiseptic Cleaning wipes-SlingFree, Band aid, Burn dressing, Burn gel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Adaptor, Hygiene | ILS | 1 | Exporter to the US | accessdata.fda.gov |
| Adhesive Backed Thermal Skin Patches | OMW | 1 | Exporter to the US | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Exporter to the US | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Cover, Cast | KIA | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Crimper, Pin | HXQ | 1 | Exporter to the US | accessdata.fda.gov |
| Crutch | IPR | 1 | Exporter to the US | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Exporter to the US | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Exporter to the US | accessdata.fda.gov |
| Extractor, Vein | NJZ | 1 | Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Manufacturer | accessdata.fda.gov |
| Iodine (Tincture) | IAL | 1 | Exporter to the US | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Contract manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Exporter to the US | accessdata.fda.gov |
| Pill Crusher/Cutter | OHY | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Exporter to the US | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
| Spill Kit | PXG | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Traction | HSP | 1 | Exporter to the US | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Exporter to the US | accessdata.fda.gov |
| Stretcher, Hand-Carried | FPP | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Manufacturer | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Exporter to the US | 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 |
|---|
| March 19, 2021 | K203593 | Patient Examination Gloves | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| November 25, 2020 | K192285 | CPR Face Shield | CBP | Substantially Equivalent | Firstar Healthcare Company Limited (Guangzhou) | accessdata.fda.gov |
| July 22, 2010 | K083418 | CPR MASK | CBP | Substantially Equivalent | Firstar Healthcare Co., Ltd. | accessdata.fda.gov |
| February 6, 2006 | K051699 | SEJOY, MODEL MT-403 | FLL | Substantially Equivalent | Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2021. 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.