OptiSeal™ Valved Peelable PTFE Introducer Kit

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Model / Reference

1000092-001

Primary DI / UDI-DI

D-0821329OPTISEAL846J

Basic UDI-DI

B-0821329OPTISEAL846J

EMDN Code

C0503 Cardiovascular introducer sheaths, peel-away

Device Class

Class IIa

EU market of registration

Netherlands

EUDAMED SRN

US-MF-000032810

Authorised representative

Emergo Europe B.V. NL-AR-000000116

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• Ptfe Peelable Introducer

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• Optiseal Enpath Valved Ptfe Peelable Introducer

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