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PERNI ANALOGHI STRATEGY pz.2

by Rhein 83 S.r.l.

Ref 044PPS

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805804571ANLKK Basic UDI-DI 08059224000350UDI-DIDate24 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224000350 UDI-DI Date26 Jul 2021ListedStatusListed 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  • Withdrawn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
PERNI ANALOGHI STRATEGY pz.2 EUDAMED
Dental Attachments GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Analoghi Spaziatori
Model / Ref / Catalog
044PPS, POSITIONING PIVOTS PLAS/MODEL STRATEGYx2
Primary DI / UDI-DI
08059224000350
Basic UDI-DI
805804571ANLKK
FDA Product Code
NDP
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
044PPS
GUDID
POSITIONING PIVOTS PLAS/MODEL STRATEGYx2
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000005998

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Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No