Skip to content

PROS Wedge with Handle

by HoverTech International EUDAMEDGUDID

Active European Union

Ref PROS-WHModel PROS-Wedge WH

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-PROS-Wedge-WHD5 Basic UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-PROS-Wedge-WHD5 UDI-DIDate6 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
PROS Wedge with Handle EUDAMED
HoverMatt PROSWedge GUDID
Generic Name
Freestanding patient positioner, single-use
Model / Reference
PROS-Wedge WH, PROS-WH
Primary DI / UDI-DI
D-PROS-Wedge-WHD5 EUDAMED
00816299013337 GUDID
Basic UDI-DI
B-PROS-Wedge-WHD5
FDA Product Code
FMP
EMDN Code
Z12011299 Patient positioning instruments – other
GMDN Term
Freestanding patient positioner, single-use
Device Class
Class I
Regulation Number
880.6450
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-PROS-Wedge-WHD5
GUDID
00816299013337

Manufacturer details

EUDAMED SRN
US-MF-000008435
Authorised representative
Etac Supply Center AB SE-AR-000001601

Other devices from Hovertech International

See all devices from Hovertech International →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No