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Teleflex Medical OEM

USA · Plymouth MN · www.teleflexmedicaloem.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN IE-MF-000015868Unified social credit code 951867330951867330

This company has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets. EU UDI-DI records ≥214, 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

≥214UDI-DI device records

Class I 59Class IIa 42Class IIb 113

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

8listed device types

Class I 1Class II 7Class III 0

plus 11 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

155registered device records

Class I 35Class IIa 91Class IIb 15Class III 14

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

4active ARTG entries

Class I 4

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 Union4,763 raw hits, 86 excluded, 214 confirmed. Large result set — only the first 300 verified

United States11 registration records, 0 510(k), 0 PMA, 5 excluded

United Kingdom155 confirmed, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Teleflex Medical OEM LLC

Regulatory identity

EU manufacturer SRN: IE-MF-000015868
EU authorised representative: Teleflex Medical
UK responsible person: Intuitive Surgical Ltd
Unified social credit code: 951867330951867330
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	14026704944146	Cough cap	Class I
EU	14026704945198	Flex. inner cannula	Class IIb
EU	14026704944153	Sealing cap	Class I
EU	14026704944139	Shower cap	Class I
UK	42412	8 mm Bladeless Obturator	Class IIa
UK	32202	CORR-A-FLEX TUBING,100 FT ROLL	Class IIa
UK	35142	MASK,AEROSOL,ELONG,PED,INTL	Class IIa

Teleflex Medical OEM

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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