CLAYENS FITCHBURG, MA

FDA Device Registration & Listing · Fitchburg, MA, US · Registration 3004014152

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004014152
FEI Number
3004014152
Entity Name
CLAYENS FITCHBURG, MA
City/State/Country
Fitchburg, MA, US
Establishment Address
180 AUTHORITY DR, Fitchburg, MA 01420, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Clayens Fitchburg (Owner Number: 10094219)
Owner / Operator Contact Address
180 Authority Drive, Fitchburg, MA 01420, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EpiFuse Alimed

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2025-11-19
FOB Bedpan General Hospital Class 1 880.6730 2025-11-19

Official Correspondent

Sabrina Guehl

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Clayens Fitchburg
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3006946348 RAUMEDIC - Muenchberg Helmbrechts Bavaria, DE
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US
2134812 VASCULAR SOLUTIONS LLC Maple Grove, MN, US
3015859709 Arrow International, LLC (subsidiary of Teleflex Incorporated) Wyomissing, PA, US
2030624 Isomedix Operations, Inc. Temecula, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004014152. Last updated year: 2026. Please use registration number 3004014152 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.