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PROS-Wedge w/ Tail

by HoverTech International

Ref PROS-TAILModel Positioning Device

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081629901PWTZ Basic UDI-DI 00816299012736UDI-DIDate11 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00816299012736 UDI-DI Date16 Apr 2024ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
PROS-Wedge w/ Tail EUDAMED
PROS Tail GUDID
Generic Name
Freestanding patient positioner, single-use
Model / Ref / Catalog
Positioning Device, PROS-TAIL
Primary DI / UDI-DI
00816299012736
Basic UDI-DI
081629901PWTZ
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
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

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

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

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