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Pkit, Trios, Sg Chest, Hip Covers, 1/Ea

by Mizuho Orthopedic Systems, Inc. EUDAMEDGUDID

Active European Union

Ref 5844-5

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0842430158956Y Basic UDI-DIDate2 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00842430110801 UDI-DIDate5 Aug 2019ListedStatusListed 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  • Withdrawn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

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Pkit, Trios, Sg Chest, Hip Covers, 1/Ea EUDAMED
Pkit, Trios, Sg Chest, Hip Covers GUDID
Generic Name
Surgical linen/cushion set
Device Name
Operating Table Accessories
Model / Ref / Catalog
5844-5, 5844-6
Primary DI / UDI-DI
00842430110801
Basic UDI-DI
0842430158956Y
FDA Product Code
KME
EMDN Code
Z12011285 Patient positioning instruments - consumables
GMDN Term
Surgical linen/cushion set
Device Class
Class I
Regulation Number
880.6060
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000002901
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Mizuho Orthopedic Systems, Inc.

See all devices from Mizuho Orthopedic Systems, Inc. →

Properties

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

Other properties (19)

  • Sterile: 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