Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025432964

FEI Number

3025432964

Entity Name

CLAYENS Crystal Lake , LLC

City/State/Country

Crystal Lake, IL, US

Establishment Address

815 Tek Dr,, Crystal Lake, IL 60014, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CLAYENS NP USA, INC (Owner Number: 10087832)

Owner / Operator Contact Address

815 TEK DR, Crystal Lake, IL 60014, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Enteral Syringe, Sterile Syringe, Piston 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	2026-03-17
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-04-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-04-19
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-04-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-03-17
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-04-19
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2024-04-10
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-04-19
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-04-19
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-04-19
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2023-04-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-04-19

Official Correspondent

Prathyusha Doddapaneni

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CLAYENS NP USA, INC

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
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
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 3025432964. Last updated year: 2026. Please use registration number 3025432964 when referencing this establishment in official correspondence.