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Creo Medical

✓ Record-verifiedregistrations found in 6 marketsEU SRN ES-MF-000000385

This company has registrations in European Union, United States, United Kingdom, Singapore, Australia, Israel — 6 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

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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

Regulatory identity

EU manufacturer SRN: ES-MF-000000385
UK responsible person: Creo Medical Ltd
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

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)

Market	Identifier	Name	Class / date
EU	08436037134975	ScopeClean - cleaning brush, single brush of 3 mm, sheath Ø 1,6 mm, length 180 cm	Class I
EU	08436037137013	ScopeClean - external cleaning brush, straight, hard bristles, bristles length 1,5 cm, length 5,5 cm	Class I
EU	08436037137006	ScopeClean - external cleaning brush, straight, soft bristles, bristles length 2 cm, length 5,5 cm	Class I
EU	08436037136993	Kit 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
UK	33579	AQUA:MASTER	Class IIa
UK	67427	Proximal Connector	Class I
UK	47487	Reusable Interface Cable 1.5M	Class I
US	K242774	SpydrBlade Flex Instrument (PRD-RG1-001)	2025-06-06
US	K242983	CROMA Electrosurgical Generator (PRD-EMR-050)	2025-02-05
US	K242061	Reusable Interface Cable 1.5 m (PRD-IFC-002)	2024-08-15

Creo Medical

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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