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ULRICH GMBH & CO. KG

Germany · Ulm

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

42listed device types

Class I 29Class II 13Class III 0

plus 65 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 10Class II 9

30 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 6Class III 3

26 including historic records

TWTaiwanTFDA

11valid device licences

Class I 1Class II 9Class III 1

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

21active ARTG entries

Class I 7IIa 3IIb 10Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 5Class 2a 1Class 2b 2Class 3 1

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 States65 registration records, 24 510(k), 0 PMA, 6 excluded

Brazil19 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada9 confirmed, 1 excluded

Manufacturer names merged into this page: ULRICH GMBH & CO. KG · ULRICH AG · ULRICH GMBH & CO.KG. · ULRICH GMBH & CO KG

FDA 510(k) clearances by year

12005

12006

12008

12009

12010

32011

22012

22013

12015

22016

12017

12019

22020

12021

22024

22025

FDA listed device types

showing 8 of 42

Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Spinal Vertebral Body Replacement Device 1Bone Cement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252281	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)	2025-11-18
US	K251295	ulrichINJECT CT Motion (XD 8000)	2025-11-07
US	K241850	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)	2024-08-26
BR	10210550094	Caixa de Instrumental para Cirurgias de Coluna Mambo	Class I
BR	10210550124	CÂNULA DESCARTÁVEL PARA INJEÇÃO DE CIMENTO ÓSSEO uCENTUM	Class II
BR	10210550122	CÂNULA DESCARTÁVEL PARA INJEÇÃO DE CIMENTO ÓSSEO TANGO RS	Class II
CA	68549	VERTEBRAL BODY REPLACEMENT (VBR)	Class III
CA	69398	BALBINA MINIMOBILE TOURNIQUET	Class II
CA	69399	KARIBA AUTOMATIC TOURNIQUET	Class II