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Bk Crani Transducer Intg Kit Al

by Medtronic Navigation Inc.

Ref 9736695

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00034918L Basic UDI-DI 00199150067664UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00199150067664 UDI-DI Date11 Apr 2026ListedStatusListed 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 23 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  • Withdrawn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
Stealth AXiS
Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT
Generic Name
Multi-purpose stereotactic surgery system
Device Name
Bk Crani Transducer Intg Kit Al
Model / Reference
9736695
Primary DI / UDI-DI
00199150067664, 00763000994570
Basic UDI-DI
0763000B00034918L
510(k) Number
FDA Product Code
HAW
EMDN Code
Z12100680 Stereotactic neurosurgery instruments - hardware accessories
GMDN Term
Multi-purpose stereotactic surgery system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560
Medical Purpose
Хирургични процедури на черепа
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-PR-000014543

Other devices from Medtronic Navigation, Inc.

See all devices from Medtronic Navigation, Inc. →

Properties

  • Lot / Batch Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Manufacturing Date: No