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BodyFIX P10104-300

by 3C-Medical Intelligence GmbH

BodyFIX P10104-300 is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by 3C-Medical Intelligence GmbH, listed in FDA GUDID since 23 Aug 2016 (UDI-DI 04056719000660), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04056719000660 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
BodyFIX
Generic name
Stereotactic radiosurgical/radiotherapy arch head frame
Model / Ref / Catalog
P10104-300
Description
BlueBAG™ HeadFIX® Rectangular 250x350mm/1,5L custom-formed vacuum cushion provides comfortable support for the head.
Primary DI / UDI-DI
04056719000660
FDA product code
IYE
GMDN term
Stereotactic radiosurgical/radiotherapy arch head frame
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stereotactic radiosurgical/radiotherapy arch head frame

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from 3C-Medical Intelligence GmbH

See all devices from 3C-Medical Intelligence GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)