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Inseritore-Tester Easy Fix

by Rhein 83 S.r.l.

Ref 190IEF

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
United StatesGUDID listing GUDID Number08059224205472 UDI-DI Date30 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805804571STRPB Basic UDI-DI 08059224205472UDI-DIDate24 Jan 2025RegisteredStatusActive

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  • Withdrawn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
Inseritore-Tester Easy Fix EUDAMED
Ot Equator GUDID
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
Strumenti (Regola 1)
Model / Ref / Catalog
190IEF, INSERTER-TESTER TOOL EASY FIX
Primary DI / UDI-DI
08059224205472
Basic UDI-DI
805804571STRPB
FDA Product Code
NDP
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
GMDN Term
Surgical instrument handle, non-torque-limiting
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 · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
190IEF
GUDID
INSERTER-TESTER TOOL EASY FIX

Manufacturer details

EUDAMED SRN
IT-MF-000005998

From the manufacturer

Manufacturer's product page: EASY FIX

Other devices from Rhein 83 S.r.l.

See all devices from Rhein 83 S.r.l. →

Properties

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