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Sitting Position Frame with Side Rail Clamp

by MIZUHO Corporation

Ref 07-953-01

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

Sitting Position Frame with Side Rail Clamp is a medical device designed to support patients in various positions, providing optimal comfort and minimizing discomfort during medical procedures. Its adjustable side rail clamp allows for customized fit and secure positioning.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number49463290307003UC Basic UDI-DI 04946329062380UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04946329062380 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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
Sitting Position Frame with Side Rail Clamp EUDAMED
Multipurpose Head Frame GUDID
Generic Name
Skull clamp
Device Name
Multi-purpose HEAD FRAME
Model / Ref / Catalog
07-953-01
Primary DI / UDI-DI
04946329062380
Basic UDI-DI
49463290307003UC
Direct Marketing DI
04946329062380
FDA Product Code
HBL
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
GMDN Term
Skull clamp
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4460
Market of Registration
Finland
GUDID distribution status
In Commercial Distribution
Size
Length — 645.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No