Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018782623

FEI Number

1419377

Entity Name

WOODSTOCK STERILE SOLUTIONS, INC.

City/State/Country

Woodstock, IL, US

Establishment Address

2210 Lake Shore Drive, Woodstock, IL 60098, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Woodstock Sterile Solutions, Inc. (Owner Number: 10081621)

Owner / Operator Contact Address

2210 Lake Shore Drive, Woodstock, IL 60098, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K935540

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Woodstock Sterile Solutions, 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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Similar Registrations

Registration Number	Establishment Name	Location
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018782623. Last updated year: 2026. Please use registration number 3018782623 when referencing this establishment in official correspondence.