Xiamen Firstcare IMP. & EXP. Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 40 device types.
Xiamen Firstcare IMP. & EXP. Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Crutch, Oximeter and 38 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | XIAMEN FIRSTCARE IMP. & EXP. CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015422337 |
| FEI number | 3015422337 |
| Establishment type | Exporter |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | 602-1, Bldg. 2A, Torch Xinke Plaza, No.2 Weili Road |
| Postal code | 361015 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Nasopharyngeal | Class 1 | Airway, Nasopharyngeal, Nasopharyngeal Airway | 2020 | 52 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Airway, Anesthesiology – Oropharyngeal Airway, Oropharyngeal | 2019 | 84 |
| Bandage, Elastic | Class 1 | Elastic Bandage | 2021 | 280 |
| Bedding, Disposable, Medical | Class 1 | Emergency Foil Blanket, Emergency Space Blanket, Emergency Blanket, Mylar Blanket | 2022 | 308 |
| Blood Pressure Cuff | Class 2 | Blood Pressure Meter Model Max0203 (Blue, Pink or Black cuff) | 2020 | 50 |
| Clinical Electronic Thermometer | Class 2 | Electronic Thermometer, Digital Thermometer | 2026 | 49 |
| Clip, Removable (Skin) | Class 1 | Zzips, Zzips 2 Pack, Zzips CUT KIT, Wound Closure Device | 2022 | 15 |
| Continuous Measurement Thermometer | Class 2 | IR Thermometer, NON-Contact Digital Thermometer, NON-Contact Infrared Thermometer, JXB-178 Infrared Thermometer, Thermometer sheaths | 2020 | 115 |
| Crutch | Class 1 | Aluminum Crutches | 2022 | 112 |
| Depressor, Tongue, Non-Surgical | Class 1 | Depressor, Tongue Depressor, Non-Surgical Tongue Depressor | 2022 | 100 |
| Device, Pressure Applying | Class 1 | Silicone Massage Cup, Silicone Cupping Set, Pressure Applying – Kangzhu Cupping Kit | 2019 | 36 |
| Disinfectant, Medical Devices | Class 1 | Alcohol prep pad, Antiseptic wipes, Alcohol swab sticks, Antiseptic cleaning wipe | 2020 | 197 |
| Dressing, Compression | Class 1 | Compressed Gauze, Emergency Pressure Bandage, Compressed Krinkle Gauze | 2022 | 87 |
| Dressing, Wound, Drug | Class U | Silver Alginate Dressing | 2026 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Burn Gel, Burn Dressing | 2026 | 118 |
| Dressing, Wound, Occlusive | Class 1 | Chest Seal | 2026 | 183 |
| Fentanyl And Other Opioid Protection Glove | Class 1 | Polymer Patient Examination Glove, Nitrile Medical Glove, Nitrile Patient Examination Glove | 2025 | 29 |
| First Aid Kit Without Drug | Class 1 | Empty First Aid Bag, Empty First Aid Box, First Aid Kit without drug, First Aid Kit Bag with CPR Face Shield, Metal First Aid Kit Box | 2019 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Pad | 2021 | 266 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Class U | Zeolite Hemostatic Gauze, Hemostatic Gauze | 2025 | 10 |
| Light, Examination, Medical, Battery Powered | Class 1 | Plastic Penlight, Disposable Penlight, Reusable Penlight, Aluminum Penlight | 2024 | 53 |
| Lubricant, Patient | Class 1 | Packet of Lube | 2026 | 33 |
| Mask, Oxygen | Class 1 | Oxygen Mask, CPR Face Shield, Face Shield | 2020 | 126 |
| Medical Glove, Specialty | Class 1 | Polymer Patient Examination Glove, Nitrile Medical Glove, Nitrile Patient Examination Glove | 2025 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Polymer Patient Examination Glove, Nitrile Medical Glove, Nitrile Patient Examination Glove | 2025 | 32 |
| Mouthpiece, Breathing | Class 1 | CPR Face Shield, CPR Shield | 2019 | 67 |
| Non-Surgical Gown | Class 1 | Disposable Isolation Gowns | 2020 | 318 |
| Orthosis, Cervical | Class 1 | Cervical Collar, Adjustable Cervical Collar | 2026 | 114 |
| Oximeter | Class 2 | Finger Pulse Oximeter | 2026 | 70 |
| Pack, Hot Or Cold, Disposable | Class 1 | Hot or Cold Pack Disposable, Disposable Hot or Cold Pack, Instant HOT Pack, Instant Cold Pack | 2020 | 176 |
| Polymer Patient Examination Glove | Class 1 | Medical Nitrile Glove, Nitrile Glove, Powder Free Nitrile Patient Examination Glove, Polymer Patient Examination Glove, Non-Powdered Patient Examination Glove, Nitrile Medical Glove and 5 more | 2023 | 83 |
| Scissors, Medical, Disposable | Class 1 | EMT Shears, Bandage Scissors | 2026 | 36 |
| Skin Prep Tray | Class 1 | Skin Prep Tray | 2025 | 8 |
| Sling, Arm | Class 1 | Triangular Bandage | 2026 | 126 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | Leg Splint, Flat Splint | 2026 | 62 |
| Splint, Hand, And Components | Class 1 | Finger Splint | 2026 | 144 |
| Stethoscope, Manual | Class 1 | Blood Pressure Meter Model Max0203 (Blue, Pink or Black cuff) | 2020 | 64 |
| Sunglasses (Non-Prescription Including Photosensitive) | Class 1 | NON-Prescription Sunglasses, Sunglasses with Impact Resistant Lenses | 2020 | 522 |
| Tape And Bandage, Adhesive | Class 1 | Tape AND Bandage, Adhesive, Adhesive Bandages | 2020 | 353 |
| Valve, Non-Rebreathing | Class 2 | CPR Mask without Oxygen Port, Non-Rebreathing Valve (18.5mm), Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), CPR Mask with Oxygen Port | 2020 | 19 |
Clearances
No clearance names Xiamen Firstcare IMP. & EXP. Co., Ltd. as applicant. 13 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 |
|---|---|---|---|---|
| K240361 | 2024-04-04 | LZA | Traditional | Hebei Titans Hongsen Medical Technology Co., Ltd. |
| K233598 | 2024-01-26 | LZA | Traditional | Anhui Intco Medical Products Co., Ltd. |
| K221979 | 2022-10-16 | DQA | Special | Shenzhen Imdk Medical Technology Co., Ltd. |
| K211570 | 2022-02-10 | QSY | Traditional | Hangzhou ZEO-Innov Life Technology Co., Ltd. |
| K202009 | 2021-03-22 | FLL | Traditional | Shenzhen Juzhong Technology Co., Ltd. |
| K190902 | 2019-05-22 | DXQ | Traditional | Wenzhou Renhua Instruments Co., Ltd. |
| K171961 | 2017-11-17 | CBP | Traditional | Xiamen Compower Medical Tech. Co., Ltd. |
| K150340 | 2015-06-18 | LZA | Traditional | Hebei Hongsen Plastics Technology Co., Ltd. |
| K143335 | 2015-06-01 | FRO | Traditional | Roosin Medical Devices Co., Ltd. |
| K130231 | 2013-10-15 | FLL | Abbreviated | Jinxinbao Electronic Co., Ltd. |
| K131440 | 2013-09-25 | LZA | Traditional | Hebei Hongsen Plastics Technology Co., Ltd. |
| K121526 | 2012-08-03 | LZA | Traditional | Shandong Junchi Medical Products Co., Ltd. |
| K935037 | 1994-04-29 | HQY | Traditional | Xiamen Chenyi Plastics Industrial Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | first aid bags, ambu bags, CPR pocket masks, laryngeal mask airways, stethoscopes, sphygmomanometers |
|---|
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.