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RadQual BM08-37

by Radqual, LLC

Part of a family of 7 devices: see the family page

Ref BM08-37

RadQual BM08-37 is a Class I device made by Radqual, LLC, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 0085002047RODUE) and listed in FDA GUDID since 3 Aug 2020 (UDI-DI 00850020470457), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0085002047RODUE Basic UDI-DI 00850020470457UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850020470457 UDI-DI Date3 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0085002047RODUE registered 7 May 2026 Active
  • FDA GUDID UDI-DI 00850020470457 listed 3 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850020470457
  2. Registered EUDAMED 0085002047RODUE

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  • Withdrawn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
RadQual
Generic name
Radionuclide source, quality assurance
Device name
Rod Sources
Model / reference
BM08-37
Primary DI / UDI-DI
00850020470457
Basic UDI-DI
0085002047RODUE
FDA product code
IXD
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Radionuclide source, quality assurance
Device class
Class I
Regulation number
892.1400
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radionuclide source, quality assurance

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Radqual, LLC

See all devices from Radqual, LLC →

Properties

  • Premarket exempt
Other properties (24, all answered No)