Creagh Medical Ltd. Dba Surmodics, Inc.
Ireland · Ballinasloe
✓ Record-verifiedregistrations found in 9 markets
This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 overseas markets. The China NMPA lookup is still pending.
Registrations by market
Each market counts a different unit; figures are not directly comparableCNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 4Class III 1
plus 12 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class II 5
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
2active device licences
Class IV 2
3 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class IV 1
ILIsraelAMAR
1registrations
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.
Australia, Hong Kong, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
How these numbers were verified
record-verifiedCompany-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 States12 registration records, 8 510(k), 0 PMA
Brazil5 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: Creagh Medical Ltd. · CREAGH MEDICAL LIMITED · CREAGH MEDICAL LTD. · Creagh Medical Ltd
Same-named companies — This database also contains companies with near-identical names: CREAGH MEDICAL LIMITED, Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics. Company name alone cannot separate their registrations, so the figures below may include either.
Company information
- Country
- Ireland
- City
- Ballinasloe
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.
FDA 510(k) clearances by year
12010
12011
12017
12018
12020
12021
12023
12024
FDA listed device types
Catheter, Intravascular Occluding, Temporary 1Introducer, Catheter 1Catheter, Percutaneous 1Catheter, Angioplasty, Peripheral, Transluminal 1Drug-Eluting Peripheral Transluminal Angioplasty Catheter 1
Registration details (sample)
| Market | Identifier | Name | Class / date |
|---|
| US | K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | 2024-11-15 |
| US | K230191 | Arise UHP Dilatation Catheter | 2023-03-22 |
| US | K211044 | Sublime Radial Access 018 RX Dilatation Catheter | 2021-06-16 |
| BR | 10212999033 | CATETER BALÃO PARA DILATAÇÃO ADVANCE SERENITY 14 | Class II |
| BR | 80312279063 | CATETER BALÃO PARA DILATAÇÃO PERIFÉRICA DE ALTA PRESSÃO PASSEO-35 HP | Class II |
| BR | 10212999029 | CATETER BALÃO PARA DILATAÇÃO ADVANCE SERENITY 18 | Class II |
| CA | 79609 | OPTIMUS PTA BALLOON DILATATION CATHETER | Class IV |
| CA | 92292 | HIGH PRESSURE PERIPHERAL DILATION CATHETER | Class IV |
Signed in · open all 17 sampled records for this company and export → · Export rows left this month —/100