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Intra Special Catheters GmbH

Germany · Rehlingen-Siersburg · www.intra-online.de

✓ Record-verifiedregistrations found in 6 marketsEU SRN DE-MF-000005178

This company has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel — 6 overseas markets. 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

8UDI-DI device records

Class I 2Class IIa 6

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

3registered devices

Class II 3

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

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 Union8 raw hits, 0 excluded, 8 confirmed

United States0 registration records, 1 510(k), 0 PMA, 1 excluded

United Kingdom1 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: INTRA SPECIAL CATHETERS.

Regulatory identity

EU manufacturer SRN: DE-MF-000005178
UK responsible person: Advena Ltd

Business registration

LEI: 967600XK6EQ4TBXBPZ79
Registration status: Active
Legal form: Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated: 1976-12-09
Registration authority: Commercial Register, no. HRB 25175
Registry record updated: 2026-07-16

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

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04025562410247	Microseld PTFE Arterial Catheter 2F - 4cm	Class IIa
EU	04025562500016	Pneumocath 8F - 50cm	Class IIa
EU	04025562010492	Auffangbeutel	Class I
EU	04025562400590	MICROSELD®, PEBA Arterienkatheter Set nach Seldinger-Technik zur Blutdruckmessung,Blutentnahme und intraarteriellen Schmerztherapie	Class IIa
UK	61345	Microseld	Class IIa
US	K955474	NEO-PNEUMOCATH	1996-02-13
BR	10289689063	Cateter para drenagem torácica com acessórios Pneumocath	Class II
BR	10289680082	Cateter para drenagem externa torácica Pneumocath	Class II
BR	10289680161	Cateter para puncao arterial em PTFE Microseld	Class II

Intra Special Catheters GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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