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Varian Applicator Assy, 6X6 Cm 65.4 Mlc

by Varian Medical Systems, Inc.

Ref 886800157

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00899475002998 UDI-DI Date17 Oct 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number089947500200137PX Basic UDI-DI 00899475002998UDI-DIDate16 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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

Recalls

1 recall · FDA

    • Terminated Z-0077-2017 FDA Class II initiated 13 Sep 2016

    Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Varian Applicator Assy, 6X6 Cm 65.4 Mlc EUDAMED
Not in use GUDID
Generic Name
Stereotactic radiosurgical invasive head frame
Device Name
Electron Applicator
Model / Reference
886800157 EUDAMED
99 GUDID
Primary DI / UDI-DI
00899475002998
Basic UDI-DI
089947500200137PX
510(k) Number
FDA Product Code
IYE
EMDN Code
Z11010199 Linear accelerators – other
GMDN Term
Stereotactic radiosurgical invasive head frame
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
886800157
GUDID
99
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

Other devices from Varian Medical Systems, Inc

See all devices from Varian Medical Systems, Inc →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No