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Veriton Nm 200

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 8010184-01Model VERITON NM

by Spectrum Dynamics Medical ltd

Identity

Trade Name
VERITON NM 200 EUDAMED
VERITON NM FDA UDI
Generic Name
SPECT system, annular detector array FDA UDI
Device Name
VERITON NM SPECT system EUDAMED
Single Photon Emission Computed Tomography System FDA UDI
Model / Reference
VERITON NM EUDAMED
8010184-01 EUDAMED
001 FDA UDI
Description
Single Photon Emission Computed Tomography System FDA UDI

Identifiers

Catalog Number
8010184-01 FDA UDI
Primary DI / UDI-DI
07290108670103 EUDAMEDFDA UDI
Basic UDI-DI
729010867VERITONXF EUDAMED
Direct Marketing DI
07290108670103 EUDAMED
510(k) Number
K180514 FDA UDI
FDA Product Code
KPS FDA UDI
EMDN Code
Z11020105 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION EUDAMED
GMDN Term
SPECT system, annular detector array FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1200 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Veriton Nm 200 by Spectrum Dynamics Medical ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Dynamics Medical ltd
EUDAMED SRN
IL-MF-000013887
Authorised Representative
SPECTRUM DYNAMICS MEDICAL FRANCE SAS FR-AR-000013226

Sources (2)

  • EUDAMED b4412ce6-ab50-4780-a9c8-0a6b184ffc8d 61 fields · synced Aug 3, 2026
  • FDA UDI f34b1d28-1aff-419c-8178-894310d5a2c2 35 fields · synced May 29, 2026