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Mayfield® A1011

by Integra Lifesciences Corp.

Part of a family of 8 devices: see the family page

Ref A1011

Mayfield® A1011 is a Class I device made by Integra Lifesciences Corp., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 038178B0041CSS2M) and listed in FDA GUDID since 19 Apr 2018 (UDI-DI 10381780267430), 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 Number038178B0041CSS2M Basic UDI-DI 10381780267430UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780267430 UDI-DI Date19 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038178B0041CSS2M registered 6 Jul 2026 Active
  • FDA GUDID UDI-DI 10381780267430 listed 19 Apr 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780267430
  2. Registered EUDAMED 038178B0041CSS2M

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  • Withdrawn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
Mayfield®
Generic name
Operating/examination/treatment table headrest, reusable
Device name
Mayfield Headrests
Model / Ref / Catalog
A1011
Primary DI / UDI-DI
10381780267430
Basic UDI-DI
038178B0041CSS2M
Direct marketing DI
10381780267430
FDA product code
HBM
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Operating/examination/treatment table headrest, reusable
Device class
Class I
Regulation number
882.4440
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Operating/examination/treatment table headrest, reusable

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)