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DTX Studio Clinic 4.4 for Win 64-bit

by Nobel Biocare AB

Ref 300851_V4.4_WIN64

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

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/MDR EUDAMED Number73327470000002206S Basic UDI-DI 07332747219616UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07332747219616 UDI-DI Date26 Jan 2025ListedStatusListed GUDID: not 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
DTX Studio Clinic 4.4 for Win 64-bit EUDAMED
DTX Studio™ Clinic GUDID
Generic Name
Radiology DICOM image processing application software
Device Name
Diagnostic and treatment software
Model / Ref / Catalog
300851_V4.4_WIN64 EUDAMED
4.4 GUDID
300851 GUDID
Primary DI / UDI-DI
07332747219616
Basic UDI-DI
73327470000002206S
510(k) Number
FDA Product Code
LLZ, MYN
EMDN Code
Z11069082 Various digital bioimaging management instruments - software accessories
GMDN Term
Radiology DICOM image processing application software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.2050, 892.2070
Special Device Type
Software
EU market of registration
Sweden
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
300851_V4.4_WIN64
GUDID
4.4
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000000009

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See all devices from Nobel Biocare AB →

Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • 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