HomeSpainCreo Medical S.L

Creo Medical S.L

Spain · Orcoyen · www.creomedical.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN ES-MF-000000385

This company has registrations in European Union, United States, United Kingdom, Israel — 4 overseas markets. EU UDI-DI records ≥67, the first 300 verified individually. 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
≥67UDI-DI device records
Class I 67
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 6 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
18registered device records
Class I 8Class IIa 5Class IIb 4System or Procedure Pack 1
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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.

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.

European Union615 raw hits, 233 excluded, 67 confirmed. Large result set — only the first 300 verified
United States6 registration records, 10 510(k), 0 PMA, 1 excluded
United Kingdom18 confirmed, 2 excluded
Manufacturer names merged into this page: CREO MEDICAL LTD
Same-named companies — This database also contains companies with near-identical names: Creo Medical. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
ES-MF-000000385
UK responsible person
Creo Medical Ltd

Company information

Country
Spain
City
Orcoyen
Website
www.creomedical.com
Product categories
Healthcare Infrastructure, Manufacturing & QualityManufacturing, CDMO & industrial medtech

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
CREO MEDICAL SL
LEI
95980004HVNNSNQMED47
Registration status
Active
Legal form
Sociedad de Responsabilidad Limitada (S.L.)
Incorporated
2002-07-30
Registration authority
Commercial Registry, no. B-6294306-3
Registry record updated
2024-03-04

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

FDA 510(k) clearances by year

12017
22020 · K200003
12021 · K200298
32023 · K230328
12024 · K242061
22025 · K242774

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1System, Ablation, Microwave And Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08436037134975ScopeClean - cleaning brush, single brush of 3 mm, sheath Ø 1,6 mm, length 180 cmClass I
EU08436037137013ScopeClean - external cleaning brush, straight, hard bristles, bristles length 1,5 cm, length 5,5 cmClass I
EU08436037137006ScopeClean - external cleaning brush, straight, soft bristles, bristles length 2 cm, length 5,5 cmClass I
EU08436037136993Kit ScopeClean (4 pcs) - cleaning brush, double brush of 5 mm, sheath Ø 1,8 mm, length 230 cm + cleaning brush, double brush of 11 & 5 mm, length 15,5 cm + cleaning brush, single brush of 1,8 mm, sheath Ø 1 mm, Class I
UK33579AQUA:MASTERClass IIa
UK67427Proximal ConnectorClass I
UK47487Reusable Interface Cable 1.5MClass I
USK242774SpydrBlade Flex Instrument (PRD-RG1-001)2025-06-06
USK242983CROMA Electrosurgical Generator (PRD-EMR-050)2025-02-05
USK242061Reusable Interface Cable 1.5 m (PRD-IFC-002)2024-08-15

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