U&U MEDICAL TECHNOLOGY CO., LTD

FDA Device Registration & Listing · hongkong, HK · Registration 3014456066

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
3014456066
FEI Number
3014456066
Entity Name
U&U MEDICAL TECHNOLOGY CO., LTD
City/State/Country
hongkong, HK
Establishment Address
RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN ,, hongkong 11702, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
U&U Medical Technology Co., Ltd (Owner Number: 10057703)
Owner / Operator Contact Address
RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN ,, hongkong, HK-NOTA 11702, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181508
PMA Number
N/A

All Registered Proprietary Names

NEEDLE INFUSION SETS Dental Syringe PEN NEEDLE Sterilization Pouch ETO and STEAM U&U PISTON SYRINGE SAFETY NEEDLE ENTERAL SYRINGE MERIT SYRINGE CAP Insulin syringe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-09-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-07-24
EIB Syringe, Irrigating (Dental) Dental Class 1 872.4565 2020-11-09
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-04-29
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2018-05-15
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-15
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-06-21
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-09-06
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2020-12-14
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2020-11-02
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2019-09-06
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-09-06

Official Correspondent

Nick wang

US Agent Details

LI QIAN Business: Carelife USA Inc. Email: li@carelifeusa.com Phone: (770) 9356499

Related Public Records

Same Entity

U&U Medical Technology Co., Ltd
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
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
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-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014456066. Last updated year: 2026. Please use registration number 3014456066 when referencing this establishment in official correspondence.
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