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MR HDR Contour Prostate template, HDR SMN, 17G 1206-04-17G

by Mick Radio Nuclear Instrument, Inc

Ref 1206-04-17

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817330023445 Basic UDI-DI 00817330023445UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817330023445 UDI-DI Date14 Oct 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 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
CT/MR Contour Prostate Template (large) Siemens, 17G EUDAMED
MR HDR Contour Prostate template, HDR SMN, 17G GUDID
Generic Name
General-purpose brachytherapy system applicator, manual
Device Name
CT/MR Contour Prostate Template
Model / Ref / Catalog
1206-04-17 EUDAMED
1206-04-17G GUDID
Primary DI / UDI-DI
00817330023445
Basic UDI-DI
B-00817330023445
510(k) Number
FDA Product Code
JAQ
EMDN Code
Z11010380 Brachytherapy radiation systems - hardware accessories
GMDN Term
General-purpose brachytherapy system applicator, manual
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.5700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1206-04-17
GUDID
1206-04-17G
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: General-purpose brachytherapy system applicator, manual

Cleared under the same submission (K993400)

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Other devices from Mick Radio-Nuclear Instruments, Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Manufacturing Date: No