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Applicator ø 20 mm, for Proctoscope ø 26 mm

EUDAMED

Class IIa (EU MDR)

Ref GM11014110

by Varian Medical Systems, Inc.

Identity

Trade Name
Applicator ø 20 mm, for Proctoscope ø 26 mm EUDAMED
Device Name
MAASTRO Rectal Applicator Set EUDAMED
Model / Reference
GM11014110 EUDAMED

Identifiers

Primary DI / UDI-DI
00816389028098 EUDAMED
Basic UDI-DI
089947500201005PL EUDAMED
Direct Marketing DI
00816389028098 EUDAMED
EMDN Code
Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Applicator ø 20 mm, for Proctoscope ø 26 mm by Varian Medical Systems, Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000001784
Authorised Representative
Siemens Healthineers Nederland B.V. NL-AR-000000803

Sources (1)

  • EUDAMED e95a892c-ee5e-4af8-bea6-8b67c8beb571 61 fields · synced Jul 28, 2026