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Head Extension for VACB with Pad (320 mm)

by MIZUHO Corporation

Ref 08-042-05

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

Overview

The Head Extension for VACB with Pad (320 mm) is a medical device designed to provide a stable and secure connection between the nasal cavity and the external nasal pad. This innovation allows for more accurate and reliable measurements of nasal patency, which is essential for diagnosing and treating respiratory diseases.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number49463290208060UJ Basic UDI-DI 04946329193497UDI-DIDate3 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04946329193497 UDI-DI Date2 Jul 2021ListedStatusListed 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  • Withdrawn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
Head Extension for VACB with Pad (320 mm) EUDAMED
Head Extension GUDID
Generic Name
Head/neck procedure positioner
Model / Ref / Catalog
08-042-05
Primary DI / UDI-DI
04946329193497
Basic UDI-DI
49463290208060UJ
Direct Marketing DI
04946329193497
FDA Product Code
GDC
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
GMDN Term
Head/neck procedure positioner
Device Class
Class I
Regulation Number
878.4960
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution
Size
Length — 562 Millimeter

Manufacturer details

EUDAMED SRN
JP-MF-000019215
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Mizuho Corporation

See all devices from Mizuho Corporation →

Properties

  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No