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Orabloc

by Pierrel S.p.A.

Ref 20201212

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number80510405820201212WF Basic UDI-DI 08051040583000UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051040583000 UDI-DI Date30 Oct 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Orabloc EUDAMED
Orabloc - needle stick safety system GUDID
Generic Name
Needle recapping device, single-use
Device Name
Dispositivo di protezione per aghi
Model / Ref / Catalog
20201212 EUDAMED
20200707 GUDID
Primary DI / UDI-DI
08051040583000
Basic UDI-DI
80510405820201212WF
FDA Product Code
FMI
EMDN Code
T0399 Protection devices (excluding personal protective equipment PPE) - other
GMDN Term
Needle recapping device, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5570
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
20201212
GUDID
20200707
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000029983

Other devices from Pierrel S.p.A.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • 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