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3D Interstitial Ring Applicator Set 60°

by Varian Medical Systems, Inc.

Ref GM11010190, GM11011040Model Ring Applicator Set 60°

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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
European UnionCE/MDR EUDAMED Number089947500201134PY Basic UDI-DI Date18 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810563022230 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
3D Interstitial Ring Applicator Set 60° EUDAMED
Ring Applicator Set 60° EUDAMED
Ring Applicator Set 60 degrees GUDID
3D Interstitial Ring Applicator Set 60 degrees GUDID
Generic Name
Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Model / Ref / Catalog
GM11010190, GM11011040, Ring Applicator Set 60°
Primary DI / UDI-DI
00810563022230, 00816389025806
Basic UDI-DI
089947500201134PY, 089947500201027PW
510(k) Number
FDA Product Code
JAQ
EMDN Code
Z11010380 Brachytherapy radiation systems - hardware accessories
GMDN Term
Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.5700
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
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

  • Convenience Kit YesGUDIDNoGUDID
  • Lot / Batch Number
  • Manufacturing Date NoGUDIDYesGUDID

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
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No