Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008719222

FEI Number

3008719222

Entity Name

ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

NO.510 Shunfeng Road, Linping District, HANGZHOU Zhejiang 311106, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhejiang Longde Pharmaceutical Co., Ltd (Owner Number: 10058139)

Owner / Operator Contact Address

No.510 Shunfeng Road, Linping District, Hangzhou, CN-ZJ 311106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sol-Care Safety Retractable Syringes Sol-M Catheter Tip Syringe SOL-M Slip Tip Syringe without Needle;SOL-M Eccentric Tip Syringe without Needle Sol-M Oral Dispensing Syringe Sol-M Luer Lock Syringe without Needle Sol-M Luer Adapter Sol-Care Safety Blood Collection Needle Sol-M Blood Collection Needle Sol-M TB Syringe Sol-M Insulin Syringe Sol-M Luer Lock Syringes Sol-M Slip Tip Syringes Slip Tip Syringe (Low Dead Space) with Exchangeable Needle Luer Lock Syringe (Low Dead Space) with Safety Needle Luer Lock Syringe (Low Dead Space) with Exchangeable Needle Slip Tip Syringe (Low Dead Space) without needle Luer Lock Syringe (Low Dead Space) without Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2018-07-16
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2022-12-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-11-12
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-04-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-09-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-12-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-07-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-07-16
QNQ	Low Dead Space Piston Syringe	General Hospital	Class 2	880.5860	2024-11-25

Official Correspondent

Zongbo Feng

US Agent Details

Edward Roles Business: Sol-Millennium Medical, Inc. Email: eroles@solm.com Phone: (773) 8376560

Related Public Records

Same Entity

Zhejiang Longde Pharmaceutical 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
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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

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
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3029328631	PEGASUS IMPORTS	Houston, TX, US
3012116434	ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.	Taihu Anhui, CN
3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3036722184	CMT HEALTH PTE. LTD.	Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008719222. Last updated year: 2026. Please use registration number 3008719222 when referencing this establishment in official correspondence.