Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015531959

FEI Number

3015531959

Entity Name

MING FAI ENTERPRISE (CAMBODIA) CO.,LTD

City/State/Country

Samraong Tong District Kampong Speu, KH

Establishment Address

National Road 41(Preah Ang Duong Road), Veal Vong Village,, Sen Dei Commune,, Samraong Tong District Kampong Speu 050109, KH

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ming Fai Enterprise (Cambodia) Co.,LTD (Owner Number: 10060734)

Owner / Operator Contact Address

National Road 41(Preah Ang Duong Road), Veal Vong Village, Sen Dei Commune, Samraong Tong, KH-5 050109, KH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Set, i.V. Fluid transfer CONTAINER, I.V O.R. Table Sheets Probe covers Operating Room Accessories Table Tray CONTAINER, I.V Protector, skin pressure CONTAINER, I.V Stretcher, patient restraint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-04-25
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2025-04-25
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-12-18
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2019-06-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-12-18
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2025-04-25
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2025-04-25
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-04-25
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2019-06-18
JES	Floss, Dental	Dental	Class 1	872.6390	2024-01-09
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2025-04-25
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2022-12-02
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2025-04-25

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Ming Fai Enterprise (Cambodia) 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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015531959. Last updated year: 2026. Please use registration number 3015531959 when referencing this establishment in official correspondence.