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Solid Bolus

by CDR Systems Inc. 2 variants

Part of a family of 44 devices: see the family pagePart of a family of 6 devices: see the family page

Ref S-BOLUS Sheet Series, S-BOLUS SeriesModel LT-Thermoplastic™ and Solid Bolus Series, Solid Bolus Series

Solid Bolus (S-BOLUS Sheet 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 62834193048H) and listed in FDA GUDID since 15 May 2020 (UDI-DI 00628341930406), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number62834193048H Basic UDI-DI 00628341930406UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628341930406 UDI-DI Date15 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 62834193048H registered 6 May 2026 Active
  • FDA GUDID UDI-DI 00628341930406 listed 15 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00628341930406
  2. Registered EUDAMED 62834193048H

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  • Withdrawn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
Solid Bolus EUDAMEDGUDID
Solid Bolus Sheet EUDAMED
Generic name
Patient positioning thermoplastic mould material
Device name
Solid Bolus (Sheets and Pellets)
Model / Ref / Catalog
LT-Thermoplastic™ and Solid Bolus Series EUDAMED
S-BOLUS Sheet Series EUDAMED
Solid Bolus Series EUDAMED
S-BOLUS Series EUDAMED
1 GUDID
S-Bolus GUDID
Primary DI / UDI-DI
00628341930406
Basic UDI-DI
62834193048H, 62834193418P
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Patient positioning thermoplastic mould material
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
LT-Thermoplastic™ and Solid Bolus Series
S-BOLUS Sheet Series
Solid Bolus Series
S-BOLUS Series
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)