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PREMIER MEDICAL

USA · Philadelphia

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Israel — 3 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

67listed device types

Class I 55Class II 9Class III 1unclassified 2

plus 72 registration records and 5 510(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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States72 registration records, 5 510(k), 0 PMA, 28 excluded

Brazil0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: PREMIER MEDICAL · PREMIER MEDICAL CORPORATION PRIVATE LIMITED · PREMIER MEDICAL GLOVES FACTORY · PREMIER MEDICAL USA CORPORATION

FDA 510(k) clearances by year

11988 · K884418

11989 · K894050

11990 · K896303

11994 · K942437

12011 · K111297

FDA listed device types

showing 8 of 67

Knife, Margin Finishing, Operative 1Curette, Periodontic 1Cannula, Sinus 1Unit, Examining/Treatment, Ent 1Fentanyl And Other Opioid Protection Glove 1Instrument, Hand, Calculus Removal 1Instrument, Cutting, Operative 1Elevator, Surgical, Dental 1

Market	Identifier	Name	Class / date
US	K111297	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-06-16
US	K942437	PREMIER	1994-06-15
US	K896303	BIOPSY PUNCH	1990-02-13

PREMIER MEDICAL

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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