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Box

by Hpf S.R.L. 2 variants

Ref H0058600089Model Box

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

CE MDR CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08057968714588 UDI-DI Date10 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberB-08057968714588 Basic UDI-DI 08057968714588UDI-DIDate10 Jun 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08057968714588 Basic UDI-DI 08057968714588UDI-DIDate10 Jun 2026RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Surgical instrument/implant rack
Model / Reference
Box, H0058600089
Primary DI / UDI-DI
08057968714588
Basic UDI-DI
B-08057968714588, 805796871TF0160001V4
Direct Marketing DI
08057968714588
FDA Product Code
OJH
EMDN Code
V0499 Clinical use containers (non-IVD) - other
GMDN Term
Surgical instrument/implant rack
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
IT-MF-000017541

Other devices from Hpf S.R.L.

See all devices from Hpf S.R.L. →

Properties

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

Other properties (20)

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