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SWAN MEDICAL S.L.

✓ Record-verifiedregistrations found in 4 marketsEU SRN ES-MF-000001526

This company has registrations in European Union, United States, United Kingdom, Canada — 4 overseas markets. EU UDI-DI records ≥5, 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

≥5UDI-DI device records

Class I 1Class IIa 4

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 1Class II 2Class III 0

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 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

2 including historic records

TWTaiwanTFDA

pendingnot queried

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.

European Union401 raw hits, 295 excluded, 5 confirmed. Large result set — only the first 300 verified

United States2 registration records, 1 510(k), 0 PMA

United Kingdom1 confirmed, 4 excluded

Manufacturer names merged into this page: SWAN MEDICAL SL · SWAN VALLEY MEDICAL, INCORPORATED · SWAN MEDICAL S.L.

Regulatory identity

EU manufacturer SRN: ES-MF-000001526
UK responsible person: Innovamed Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08437016917404	Rutiside	Class IIa
EU	08437016917350	RUTILIGHT	Class IIa
EU	08437016917176	—	Class IIa
EU	08437016917015	—	Class I
UK	37089	RUTILIGHT	Class IIa
US	K120127	SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM	2012-10-26

SWAN MEDICAL S.L.

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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