Skip to content

Standard Imaging MAX SD 90030

by Standard Imaging Inc.

Ref 90030

Standard Imaging MAX SD 90030 is a Class I device made by Standard Imaging Inc., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 0850019946EMETERSCINTIAU) with CE/MDR certificate 28620136130-01 valid until 18 Oct 2027 and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 00850019946109), active as of 8 Nov 2026.

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

CE MDR

Valid until

18 Oct 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850019946EMETERSCINTIAU Basic UDI-DI 00850019946109UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850019946109 UDI-DI Date22 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850019946EMETERSCINTIAU registered 13 May 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850019946109 listed 22 Jun 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620136130-01 Expiring Expires in 338 days

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    22 Feb 2023
    Expires
    18 Oct 2027

Timeline

4 dated events

  1. Certificate issued EUDAMED 28620136130-01
  2. Listed FDA GUDID 00850019946109
  3. Registered EUDAMED 0850019946EMETERSCINTIAU
  4. Certificate expires EUDAMED 28620136130-01

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MAX SD Electrometer EUDAMED
Standard Imaging MAX SD GUDID
Generic name
Radiation electrometer
Device name
Scintillator System
Model / Ref / Catalog
90030
Primary DI / UDI-DI
00850019946109
Basic UDI-DI
0850019946EMETERSCINTIAU
FDA product code
LHO
EMDN code
Z11019082 Various radiotherapy and radiosurgery instruments - software accessories
GMDN term
Radiation electrometer
Device class
Class I
Regulation number
892.1940
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation electrometer

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS.

Other devices from Standard Imaging Inc.

See all devices from Standard Imaging Inc. →

Properties

  • Measuring function
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)