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AESCULAP, INC.

Germany · Tuttlingen

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

450listed device types

Class I 343Class II 105Class III 1unclassified 1

plus 1,004 registration records and 218 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

155registered devices

Class I 107Class II 48

219 including historic records

SASaudi ArabiaSFDA

699registered imported devices

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

CACanadaMDALL

55active device licences

Class II 24Class III 26Class IV 5

87 including historic records

TWTaiwanTFDA

67valid device licences

Class I 29Class II 38

SGSingaporeHSA SMDR

93device registrations

CLASS B 59CLASS C 9CLASS D 25

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

261active ARTG entries

Class I 103Class III 77IIa 50IIb 25Class Im (measuring) 2Class Is (sterile) 4

HKHong KongMDACS

22valid listings

Class II 8Class III 3Class IV 11

ILIsraelAMAR

23registrations

RURussiaRoszdravnadzor

62active registrations

Class 1 6Class 2a 33Class 2b 11Class 3 12

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 States1,004 registration records, 218 510(k), 0 PMA, 11 excluded

Brazil155 confirmed, 3 excluded

Saudi Arabia699 confirmed, 0 excluded

Canada55 confirmed, 2 excluded

Manufacturer names merged into this page: AESCULAP AG · AESCULAP, INC. · AESCULAP SAS · Aesculap AG

FDA 510(k) clearances by year

52005

222006

42007

32008

72010

22011

52012

42013

52014

72015

32016

62017

62018

62019

62020

32021

12022

12023

12024

12025

FDA listed device types

showing 8 of 450

Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Forceps, Surgical, Gynecological 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Antisera, All Leptospira Spp. 1Cerclage, Fixation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242762	Aesculap Aicon® Series Container System	2025-05-13
US	K242003	XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set	2024-12-16
US	K223596	SQ.line KERRISON	2023-06-29
BR	10008530022	VENOSTRIP FLEBO EXTRATOR	Class II
BR	10008530186	INSTRUMENTAL PARA IMPLANTE DE TARGON - AESCULAP	Class I
BR	10008530138	INSTRUMENTAL PARA IMPLANTE DE PROTESE ACETABULARPLASMACUP	Class I
SA	ME0000000908SFDAA00077	STERILIT I OIL SPRAY	—
SA	ME0000000908SFDAA01935	MIKULICZ ABDOM.RETRACTOR	—
CA	18467	SYNTHOFIL POLYESTER SUTURE	Class III
CA	22676	UNI-GRAFT K DV PATCH	Class IV
CA	23228	MICRO SPEED EC MOTOR AND ACCESSORIES	Class II