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Intrauterine tandem, 45°, 8 cm, CT/ MR

by Varian Medical Systems, Inc.

Ref GM11012640

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
United StatesGUDID listing GUDID Number00816389029576 UDI-DI Date16 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number089947500201209Q6 Basic UDI-DI 00816389029576UDI-DIDate31 Mar 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

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  • Withdrawn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
Intrauterine tandem, 45°, 8 cm, CT/ MR EUDAMED
Intrauterine tandem, 45 degrees, 8 cm, CT/ MR GUDID
Generic Name
Vaginal brachytherapy system applicator, remote-afterloading
Device Name
Intrauterine tandems (15°, 30°, 45°), CT/MR, Intrauterine needle tandem (30°) CT/MR
Model / Ref / Catalog
GM11012640
Primary DI / UDI-DI
00816389029576
Basic UDI-DI
089947500201209Q6
510(k) Number
FDA Product Code
JAQ
EMDN Code
Z11010380 Brachytherapy radiation systems - hardware accessories
GMDN Term
Vaginal 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 Safe

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

  • Lot / Batch Number
  • Manufacturing Date

Other properties (22)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No