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BIOSEAL

USA · Placentia

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

130listed device types

Class I 93Class II 36Class III 0unclassified 1

plus 138 registration records and 10 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States138 registration records, 10 510(k), 0 PMA

Manufacturer names merged into this page: BIOSEAL · Bioseal

FDA 510(k) clearances by year

91988 · K882695

11989 · K893814

FDA listed device types

showing 8 of 130

Device, Occlusion, Umbilical 1Container, Specimen, Sterile 1Board, Arm (With Cover), Sterile 1Toothbrush, Manual 1Airway, Nasopharyngeal 1Dam, Rubber 1Orthopedic Manual Surgical Instrument 1Tourniquet, Nonpneumatic 1

Market	Identifier	Name	Class / date
US	K893814	SURGICAL INSTRUMENT KIT, DISPOSABLE	1989-08-10
US	K882695	RUBBER BAND, STERILE	1988-10-13
US	K882696	DERMICEL, MONTGOMERY STRAP	1988-08-26

BIOSEAL

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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