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OrthoEasy anchorage screw

by Bernhard Förster GmbH 4 variants

Ref 1101A2308

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

CE MDR

Valid until

5 Jun 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

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 Number++EFOR100101CZ Basic UDI-DI EFOR1101A23081UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEFOR1101A23081 UDI-DI Date15 Aug 2019ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000244470 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    6 Jun 2025
    Expires
    5 Jun 2030

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
OrthoEasy®
Generic Name
Orthodontic anchoring screw
Device Name
OrthoEasy anchorage screw
Model / Reference
1101A2308
Primary DI / UDI-DI
EFOR1101A23081
Basic UDI-DI
++EFOR100101CZ
Unit of Use DI
EFOR1101A2308001
510(k) Number
FDA Product Code
OAT
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic anchoring screw
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006256

Other devices from Bernhard Förster GmbH

See all devices from Bernhard Förster GmbH →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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