HomeCanadaSULZER CARBOMEDICS CANADA LTD

SULZER CARBOMEDICS CANADA LTD

Canada · Calgary
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
8510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 8 510(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
5active device licences
Class IV 5
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States0 registration records, 8 510(k), 0 PMA, 1 excluded
Canada5 confirmed, 1 excluded
Manufacturer names merged into this page: SULZER CARBOMEDICS CANADA LTD
Same-named companies — This database also contains companies with near-identical names: Sulzer Carbomedics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Calgary

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
Carbomedics Canada Inc.
Corporation number
3372405
Registration status
Inactive
Legal form
Canada Business Corporations Act
Incorporated
1997-05-08
Registered address
20 QUEEN STREET WEST, TORONTO, ON, M5H 3S1

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

21998 · K974648
21999 · K993288
12001 · K002007
32002 · K023185

Registration details (sample)

MarketIdentifierNameClass / date
USK023185ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 8002002-12-17
USK013022SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS2002-06-13
USK021051ANNULOFLO SYSTEM, MITRAL MODEL AR7002002-04-23
CA1444SULZER CARBOMEDIC PROSTHETIC HEART VALVE (CPHV)Class IV
CA1764SULZER CARBOMEDICS ANNULOFLO ANNULOPLASTY RINGClass IV
CA1765SULZER CARBOMEDIC CARBO-MEDIC ASCENDING AORTIC PROSTHESISClass IV

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