Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010026090

FEI Number

3010026090

Entity Name

ZHEJIANG INI MEDICAL DEVICES CO., LTD

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

NO 251 JIFENG ROAD, YONGZHONG SUB-DISTRICT, LONGWAN DISTRICT, WENZHOU Zhejiang 325024, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ZHEJIANG INI MEDICAL DEVICES CO., LTD (Owner Number: 10078208)

Owner / Operator Contact Address

NO 251 JIFENG ROAD, YONGZHONG SUB-DISTRICT, LONGWAN DISTRICT, WENZHOU, CN-ZJ 325024, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Facial Cannula DISPOSABLE INSULIN SYRINGE, MULTIPLE MODELS INSULIN PEN NEEDLE; MULTIPLE MODELS DISPOSABLE SYRINGE AND NEEDLES (1CC with and without needle) MedtPoint Livaclean Health U&U Insulin Syringes Lite Touch Prodigy JJ Care Insulin Syringe for Pets JJ Care Insulin Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-11-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-10-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-05-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-10-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-10-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-02-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2023-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

ZHEJIANG INI MEDICAL DEVICES 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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010026090. Last updated year: 2026. Please use registration number 3010026090 when referencing this establishment in official correspondence.