AMSINO MEDICAL GROUP (HK) COMPANY LIMITED

FDA Device Registration & Listing · HONG KONG, HK · Registration 3012445205

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012445205
FEI Number
3012445205
Entity Name
AMSINO MEDICAL GROUP (HK) COMPANY LIMITED
City/State/Country
HONG KONG, HK
Establishment Address
9th Floor, Tung Ning Building, 249-253 Des Voeux Road Central, HONG KONG 999077, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Amsino Medical Group (HK) Company Limited (Owner Number: 10061664)
Owner / Operator Contact Address
9th Floor, Tung Ning Building, 249-253 D, HONG KONG, HK-NOTA 999077, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K082831
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2020-12-22
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2020-12-22
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2020-12-22
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2020-12-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-12-22
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2020-12-22
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2020-12-22
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2020-12-22
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2020-12-22

Official Correspondent

Holiven Ji

US Agent Details

Richard Lee Email: holiven_ji@amsino.com Phone: (909) 6265888

Related Public Records

Same Entity

Amsino Medical Group (HK) Company Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K791969 Medline Industries, Inc. DYNACOR STERILE CLOSED SYS. DRAINAGE BAG 1979-11-05
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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3031582449 JM MEDICAL CO., LTD. Liaocheng Shandong, CN
3045058049 BOEN HEALTHCARE CO., LTD. Suzhou Jiangsu, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012445205. Last updated year: 2026. Please use registration number 3012445205 when referencing this establishment in official correspondence.
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