Excellentcare Medical (Huizhou) Ltd.
Registered establishment in Huizhou, Guangdong, China. 14 device types, 1 clearance.
Excellentcare Medical (Huizhou) Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Mask, Gas, Anesthetic and 12 other device types. Its earliest product listing with the FDA dates from 2016.
14device types registered with the FDA
1510(k) clearance
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3013507143 |
| FEI number | 3013507143 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 斯莱达医疗用品（惠州）有限公司 |
|---|---|
| Unified social credit code | 91441322661521305H |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Huizhou |
|---|---|
| Province | Guangdong |
| Address | Shatou Industrial Zone, Yuanzhou Town, Boluo County |
| Postal code | 516123 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorbent, Carbon-Dioxide | Class 1 | Soda Lime; Calcium Lime | 2016 | 4 |
| Accessory, Surgical Apparel | Class 1 | Protective goggles, model EM13-001, EM13-002, EM13-003 | 2020 | 439 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | laryngeal mask airways, PVC or Silicone, Guedel airways, 10cm, 9cm, 8cm, 7cm, 5cm, 4cm | 2016 | 84 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | Class 1 | Anaesthetic breathing circuit (Adult/Pediatric/Infant), Expandable anaesthetic breathing circuit, Anaesthetic breathing circuit Kits | 2016 | 11 |
| Cannula, Nasal, Oxygen | Class 1 | Emedical Nasal Cannula, Model: Nasal cannula, Emedical Nasal Cannula, Model: CPAP silicone nasal cannula, Emedical Nasal Cannula, Model: Soft tip nasal cannula, Emedical Nasal Cannula, Model: High flow nasal cannula, Emedical Nasal Cannula, Model: CPAP nasal cannula | 2016 | 97 |
| Catheters, Suction, Tracheobronchial | Class 1 | Sputum suction tube (basic/ closed/ collector) | 2016 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | ICU smoothbore breathing system (Adult/Pediatric/Infant), Heated wire breathing system (single or double), ICU breathing system (Adult/Pediatric/Infant) | 2016 | 55 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | HMEs-Heat and Moisture Exchange Filters, HME for tracheostomy patient | 2016 | 29 |
| Connector, Airway (Extension) | Class 1 | Catheter mounts and Connectors | 2016 | 20 |
| Mask, Gas, Anesthetic | Class 1 | Anaesthetic face mask, 1#, 2#, 3#, 4#, 5#, Anaesthetic soft cushion mask, 0#, 1#, 2#, 3#, 4#, 5# | 2016 | 71 |
| Mask, Oxygen | Class 1 | Oxygen mask, rebreathing and non-rebreathing; Tracheostomy mask; Aerosol mask | 2016 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi valves and kits | 2016 | 46 |
| Set, Tubing And Support, Ventilator (W Harness) | Class 1 | Noninvasive ventilator breathing system | 2016 | 33 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | Class 1 | Accurate urine meter | 2016 | 13 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K192971 | 2021-07-08 | CAF | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Factory area | 25,000 m² |
| Main products | breathing equipments, anaesthetic instruments, medical surgical products |
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.