Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013507143

FEI Number

3013507143

Entity Name

Excellentcare Medical (Huizhou) Ltd.

City/State/Country

Huizhou Guangdong, CN

Establishment Address

Shatou Industrial Zone, Yuanzhou Town, Boluo County, Huizhou Guangdong 516123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Excellentcare Medical (Huizhou) Ltd. (Owner Number: 10053236)

Owner / Operator Contact Address

Shatou Industrial Zone, Yuanzhou Town, Boluo County, Huizhou, CN-GD 516123, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sputum suction tube (basic/ closed/ collector) Guedel airways, 10cm, 9cm, 8cm, 7cm, 5cm, 4cm laryngeal mask airways, PVC or Silicone Noninvasive ventilator breathing system Soda Lime; Calcium Lime ICU smoothbore breathing system (Adult/Pediatric/Infant) Heated wire breathing system (single or double) ICU breathing system (Adult/Pediatric/Infant) Oxygen mask, rebreathing and non-rebreathing; Tracheostomy mask; Aerosol mask Protective goggles, model EM13-001, EM13-002, EM13-003 Venturi valves and kits HMEs-Heat and Moisture Exchange Filters, HME for tracheostomy patient Emedical Nasal Cannula, Model: Nasal cannula Emedical Nasal Cannula, Model: Soft tip nasal cannula Emedical Nasal Cannula, Model: CPAP nasal cannula Emedical Nasal Cannula, Model: High flow nasal cannula Emedical Nasal Cannula, Model: CPAP silicone nasal cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2016-12-19
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-12-19
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2016-12-19
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2016-12-19
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2016-12-19
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-12-19
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-15
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2016-12-19
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2016-12-19
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2016-12-19

Official Correspondent

Yuping Wu

US Agent Details

Simin Lin Email: simin_lin123@126.com Phone: (415) 6026843

Related Public Records

Same Entity

Excellentcare Medical (Huizhou) Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013507143. Last updated year: 2026. Please use registration number 3013507143 when referencing this establishment in official correspondence.