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Sugita Titanium Clips II Case EB for Extra B

by MIZUHO Corporation EUDAMEDGUDID

Active European Union

Ref 17-010-08

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number49463290307004UE Basic UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04946329214604 UDI-DIDate5 Apr 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR 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
Sugita Titanium Clips II Case EB for Extra B EUDAMED
Sugita Titanium Clips II Case GUDID
Generic Name
Surgical clip rack
Device Name
Sugita Clip Case
Model / Ref / Catalog
17-010-08
Primary DI / UDI-DI
04946329214604
Basic UDI-DI
49463290307004UE
Direct Marketing DI
04946329214604
FDA Product Code
HBR
EMDN Code
Z12011299 Patient positioning instruments – other
GMDN Term
Surgical clip rack
Device Class
Class I
Regulation Number
882.4215
Market of Registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 8.86 Inch

Manufacturer details

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

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Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Serial Number: No
  • Expiration Date: No