HELIOS BIOMEDICAL INC.

FDA Device Registration & Listing · Natick, MA, US · Registration 3025316685

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
3025316685
FEI Number
3025316685
Entity Name
HELIOS BIOMEDICAL INC.
City/State/Country
Natick, MA, US
Establishment Address
8 Mercer Rd, Natick, MA 01760, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Helios Biomedical Inc. (Owner Number: 10086401)
Owner / Operator Contact Address
8 Mercer Rd, Natick, MA 01760, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250397
PMA Number
N/A

All Registered Proprietary Names

CardiaMend Helios Dermal Scaffold

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2022-11-07
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2026-01-02

Official Correspondent

Susan Reilly

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Helios Biomedical 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
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025316685. Last updated year: 2026. Please use registration number 3025316685 when referencing this establishment in official correspondence.
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