Assembly, Injector, C501-10

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

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

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Assembly, Injector, C501-10 EUDAMED

Stratis® GUDID

Generic Name

Needleless medication/vaccine injector, mechanical

Device Name

Stratis Injector

Model / Ref / Catalog

C501-10

Primary DI / UDI-DI

00856457003206

Basic UDI-DI

0856457003C501STRATSINJLH

510(k) Number

K111517 ↗

FDA Product Code

KZE

EMDN Code

A020199 Syringes, single-use - other

GMDN Term

Needleless medication/vaccine injector, mechanical

Device Class

Class IIa EUDAMED

Class II GUDID

Regulation Number

880.5430

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

US-MF-000036614

Authorised representative

Emergo Europe B.V. NL-AR-000000116

• Assembly, Injector, C501-10

  Class IIa

  CE/MDR

• Assembly, Filling Adapter, Single-up, FFS, C503-42, CE

  Class I

  CE/MDR

• Assembly, Injector, C503-10

  Class IIa

  CE/MDR

• Pharmajet Needle-Free Injection System

  Class II

  FDA 510(k) K081532 Active Cleared 26 Feb 2009

• Pharmajet 0.1 Ml Intradermal Needle-Free Injection System

  Class II

  FDA 510(k) K110456 Active Cleared 2 Mar 2011

• Pharmajet Stratis 0.5 Ml Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis Reset Stati

  Class II

  FDA 510(k) K111517 Active Cleared 27 Jul 2011

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