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CT PaperRoll Holder C

by Pearl Technology AG

Ref 1272

CT PaperRoll Holder C (1272) is a Class I device made by Pearl Technology AG, registered in EUDAMED on 4 Apr 2024 (Basic UDI-DI 764017806RollHolder2B) and listed in FDA GUDID since 13 Dec 2022 (UDI-DI 07640178061491), 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 Number764017806RollHolder2B Basic UDI-DI 07640178061491UDI-DIDate4 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07640178061491 UDI-DI Date13 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764017806RollHolder2B registered 4 Apr 2024 Active
  • FDA GUDID UDI-DI 07640178061491 listed 13 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640178061491
  2. Registered EUDAMED 764017806RollHolder2B

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  • Withdrawn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
CT PaperRoll Holder C EUDAMED
pearltec GUDID
Generic name
Radiological general body-part positioner
Device name
CT PaperRoll Holder
Model / Ref / Catalog
1272 EUDAMED
ProFoam Head/Neck GUDID
1246 GUDID
Primary DI / UDI-DI
07640178061491
Basic UDI-DI
764017806RollHolder2B
Direct marketing DI
07640178061491
FDA product code
KXH
EMDN code
Z11030699 Computed tomographs (CT) - other
GMDN term
Radiological general body-part positioner
Device class
Class I
Regulation number
892.1830
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1272
GUDID
ProFoam Head/Neck

Manufacturer details

EUDAMED SRN
CH-MF-000018100
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - OTHER.

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Properties

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