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Classic Stepper 657-109

by Civco Medical Instruments Co., Inc.

Ref 657-109

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 Number00841436125451 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0841436101TD301B1NY Basic UDI-DI 00841436125451UDI-DIDate16 May 2026RegisteredStatusActive

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  • Withdrawn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
Classic Stepper
Generic Name
Prostate brachytherapy system applicator, manual
Device Name
AccuCARE Equipment & Template Grids – (Classic Steppers)
Model / Ref / Catalog
657-109
Primary DI / UDI-DI
00841436125451
Basic UDI-DI
0841436101TD301B1NY
Direct Marketing DI
20841436125431
510(k) Number
FDA Product Code
IWJ, ITX, JAQ
EMDN Code
Z11010380 Brachytherapy radiation systems - hardware accessories
GMDN Term
Prostate brachytherapy system applicator, manual
Device Class
Class I
Regulation Number
892.5650, 892.1570, 892.5700
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K131161)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No