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UNICARE BIOMEDICAL, INC.

USA · Laguna Hills

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, South Korea — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 4Class III 0unclassified 3

plus 9 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 2Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 11 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: UNICARE BIOMEDICAL, INC.

FDA 510(k) clearances by year

11998

12000

22001

22002

12008

32009

12015

FDA listed device types

Barrier, Animal Source, Intraoral 1Bone Grafting Material, Synthetic 1Plate, Bone 1Barrier, Synthetic, Intraoral 1Wound Dressing With Animal-Derived Material(S) 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1Oral Wound Dressing 1

Market	Identifier	Name	Class / date
US	K151344	Cytoflex Tefguard Ti-Enforced Membrane	2015-11-19
US	K092567	MODIFICATION TO UNIGRAFT	2009-11-25
US	K090612	BENACEL	2009-07-24

UNICARE BIOMEDICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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