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pearltec BabyFix XL

by Pearl Technology AG

Ref 1276-A

pearltec BabyFix XL (1276) is a radiological general body-part positioner (EU MDR Class I; FDA Class I; FDA product code KXH, Cradle, Patient, Radiologic) made by Pearl Technology AG, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 764017806BabyFixEK) and listed in FDA GUDID since 28 Jul 2025 (UDI-DI 07640178062078), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764017806BabyFixEK Basic UDI-DI 07640178062078UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640178062078 UDI-DI Date28 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764017806BabyFixEK registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 07640178062078 listed 28 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640178062078
  2. Registered EUDAMED 764017806BabyFixEK

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  • Withdrawn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
BabyFix XL EUDAMED
pearltec GUDID
Generic name
Radiological general body-part positioner
Device name
BabyFix
Model / Ref / Catalog
1276-A EUDAMED
BabyFix XL GUDID
1276 GUDID
Primary DI / UDI-DI
07640178062078
Basic UDI-DI
764017806BabyFixEK
Direct marketing DI
07640178062078
FDA product code
KXH
EMDN code
V080302 Patient positioning medical cushions
GMDN term
Radiological general body-part positioner
Device class
Class I
Regulation number
892.1830
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1276-A
GUDID
BabyFix XL

Related devices

Category: Radiological general body-part positioner

Similar devices in this category

Other devices filed under PATIENT POSITIONING MEDICAL CUSHIONS.

Other devices from Pearl Technology AG

See all devices from Pearl Technology AG →

Properties

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