Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032542

FEI Number

3003646540

Entity Name

UNICARE BIOMEDICAL, INC.

City/State/Country

Laguna Hills, CA, US

Establishment Address

23011 Moulton Pkwy Ste J11, Laguna Hills, CA 92653, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

UNICARE BIOMEDICAL, INC. (Owner Number: 9034652)

Owner / Operator Contact Address

23011 Moulton Pkwy, Ste J11, Laguna Hills, CA 92653, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090083

PMA Number

N/A

All Registered Proprietary Names

Unigraft Benacel Dental Dressing Curagen Benacel Plus Cytoflex Ti-Enforced Membrane Perforated Cytoflex Ti-Enforced Membrane Cytoflex Resorb

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2012-07-12
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2011-12-05
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-07-25
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2008-12-10
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2017-08-04
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2011-12-05

Official Correspondent

STAN YANG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UNICARE 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
K052493	Steiner Laboratories	SOCKET GRAFT	2006-06-09
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15

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1058584	Sterigenics US LLC	Charlotte, NC, US
3021912300	OSTEOGENE TECH CORP	Norwood, NJ, US
3003300673	Collagen Matrix, Inc	Allendale, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032542. Last updated year: 2026. Please use registration number 2032542 when referencing this establishment in official correspondence.