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asap endoscopic products GmbH

Germany · Umkirch Baden-Wurttemberg

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 5 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

8listed device types

Class I 3Class II 5Class III 0

plus 9 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 12Class II 12

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

12active ARTG entries

Class I 9IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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, 5 510(k), 0 PMA, 3 excluded

Brazil24 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: asap endoscopic products GmbH · ASAP ENDOSCOPIC PRODUCTS GMBH

FDA 510(k) clearances by year

32003 · K031974

12004 · K032822

12013 · K121261

FDA listed device types

Nasopharyngoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Hysteroscope (And Accessories) 1Arthroscope 1Laparoscope, Gynecologic (And Accessories) 1Otoscope 1Accessories, Photographic, For Endoscope (Exclude Light Sources) 1Camera, Television, Endoscopic, Without Audio 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121261	ASAP MUITISCOPE	2013-01-08
US	K032822	ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0	2004-01-08
US	K031974	ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0	2003-09-29
BR	82193580006	Instrumentos ASAP Aço inoxidável	Class I
BR	82193580007	Instrumentos ASAP Nitinol	Class I
BR	80088370038	Endoscópios Rígidos para Histeroscopia	Class II

asap endoscopic products GmbH

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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