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Pro Design Intl. AS

USA · New York

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

75listed device types

Class I 9Class II 44Class III 21unclassified 1

plus 108 registration records and 3 510(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

1active ARTG entries

Class I 1

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 States108 registration records, 3 510(k), 0 PMA, 83 excluded

Brazil0 confirmed, 23 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada0 confirmed, 9 excluded

Manufacturer names merged into this page: PRO-TECH DESIGN & MFG., INC. · PRO-TECH Design & Mfg, Inc.

FDA 510(k) clearances by year

21984 · K844658

11989 · K893055

FDA listed device types

showing 8 of 75

Knife, Ophthalmic 1Adaptor, Holder, Syringe 1Kit, Surgical Instrument, Disposable 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Garment, Storage, Peritoneal Dialysis Catheter 1Hysteroscope Accessories 1Airway, Nasopharyngeal 1Medical Glove, Specialty 1

Market	Identifier	Name	Class / date
US	K893055	LATEX EXAMINATION GLOVES	1989-08-21
US	K844658	SPECTABLE FRAME - PRODESIGN SUN CLUB	1984-12-11
US	K844657	SPECTABLE FRAME MAGNIFYING BRILLETTE	1984-12-11

Pro Design Intl. AS

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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