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Sedecal Shf-615

by Sedecal., Sa.

Part of a family of 87 devices: see the family page

Ref SHF-615Model SHF, SHFR

Sedecal Shf-615 is a device classified as Class IIb in the EU and Class I in the US made by Sedecal., Sa., registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 843604600GENERATORBD) and listed in FDA GUDID since 28 Oct 2016 (UDI-DI 08436046000384), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number843604600GENERATORBD Basic UDI-DI 08436046000384UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08436046000384 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 843604600GENERATORBD registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 08436046000384 listed 28 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08436046000384
  2. Registered EUDAMED 843604600GENERATORBD

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  • Withdrawn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
Sedecal
Generic name
Diagnostic x-ray system generator, stationary
Model / reference
SHF-615, SHF, SHFR
Primary DI / UDI-DI
08436046000384
Basic UDI-DI
843604600GENERATORBD
FDA product code
IZO
EMDN code
Z11039011 High voltage x-ray generators
GMDN term
Diagnostic x-ray system generator, stationary
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
892.1700
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Diagnostic x-ray system generator, stationary

Similar devices in this category

Other devices filed under HIGH VOLTAGE X-RAY GENERATORS.

Other devices from Sedecal., Sa.

See all devices from Sedecal., Sa. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)