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Head Support

by CDR Systems Inc.

Ref Multiple THS03 catalogue numbersModel THS03 Head Support Series

Head Support (THS03 Head Support Series) is a device classified as Class I in the EU and Class II in the US made by CDR Systems Inc, registered in EUDAMED on 6 May 2026 (Basic UDI-DI 62834193098T), cleared under FDA 510(k) K122888 on 30 Apr 2013 and listed in FDA GUDID since 31 Dec 2019 (UDI-DI 00628341930239), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122888

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number62834193098T Basic UDI-DI 00628341930239UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628341930239 UDI-DI Date31 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122888 Date30 Apr 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 62834193098T registered 6 May 2026 Active
  • FDA 510(k) K122888 decided 30 Apr 2013 Active
  • FDA GUDID UDI-DI 00628341930239 listed 31 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122888
  2. Listed FDA GUDID 00628341930239
  3. Registered EUDAMED 62834193098T

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Head Support EUDAMED
Positioning Aids GUDID
Generic name
Radiological headrest
Model / Ref / Catalog
THS03 Head Support Series EUDAMED
Multiple THS03 catalogue numbers EUDAMED
1 GUDID
THS03 GUDID
Primary DI / UDI-DI
00628341930239
Basic UDI-DI
62834193098T
510(k) Number
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Radiological headrest
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
THS03 Head Support Series
Multiple THS03 catalogue numbers
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CA-MF-000051790
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from CDR Systems Inc

See all devices from CDR Systems Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)