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HITM Red

by C-RAD Positioning AB

Part of a family of 13 devices: see the family page

Ref SP006-0011Model HITSD Red

HITM Red (SP006-0011) is a Class I device made by C-Rad Positioning Ab, registered in EUDAMED on 11 May 2022 (Basic UDI-DI 735000528HITED), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735000528HITED Basic UDI-DI 17350005280427UDI-DIDate11 May 2022RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
HITSD Red
Model / reference
HITSD Red, SP006-0011
Primary DI / UDI-DI
17350005280427
Basic UDI-DI
735000528HITED
Direct marketing DI
17350005280427
EMDN code
Z119010 Laser systems for patient positioning
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
SE-MF-000022326

Related devices

Category: Laser patient positioning system

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from C-Rad Positioning Ab

See all devices from C-Rad Positioning Ab →

Properties

Other properties (14, all answered No)