Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038294399

FEI Number

3038294399

Entity Name

CAMEDICAL TECHNOLOGY (CAMBODIA) CO., LTD.

City/State/Country

Samraong Takeo, KH

Establishment Address

Char Village, Rovieng Commune, Samraong Takeo 21000, KH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CAMEDICAL TECHNOLOGY (CAMBODIA) CO., LTD. (Owner Number: 10093319)

Owner / Operator Contact Address

Char Village, Rovieng Commune, Samraong, KH-21 21000, KH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cardinal Health Monoject Catheter Tip SYRINGE Dynarex Irrigation Syringe Dynarex Irrigation Syringe Tray Enteral Syringe Reusable ENFit Syringe SYRINGE, PISTON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-05-26
PIO	Enteral Specific Transition Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-05-26
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-12-02
PPA	Bladder Irrigation Kit	Gastroenterology, Urology	Class 2	876.5130	2025-12-06
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2026-03-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-03-10
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-12-02
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-03-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-09-24
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2025-07-11

Official Correspondent

Angela Jiang

US Agent Details

Bryan Wong Business: PureVision Ai, Inc. Email: info@pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

CAMEDICAL TECHNOLOGY (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
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3004099493	CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD.	Chengdu Sichuan, CN
2029275	Sterigenics U.S., LLC	Corona, CA, US
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
3009742443	JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD	Yangzhou Jiangsu, CN
3005934752	MEDXL INC	Pointe-Claire Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038294399. Last updated year: 2026. Please use registration number 3038294399 when referencing this establishment in official correspondence.