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Ss Archwire Natural Upper 019X025 W/100

by Aditek do Brasil SA

Ref 09.05.0595.0, 09.05.0595.0IModel Archwires and Wires

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number7899439209JC Basic UDI-DI Date1 Aug 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number7899439209JC Basic UDI-DI Date1 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07899439277755 UDI-DI Date15 Sep 2023ListedStatusListed 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  • Withdrawn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/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ss Archwire Natural Upper 019X025 W/100 EUDAMED
SS Archwire Natural Upper 019X025 Individual w/100 EUDAMED
Aditek GUDID
Generic Name
Orthodontic wire
Model / Reference
Archwires and Wires, 09.05.0595.0, 09.05.0595.0I
Primary DI / UDI-DI
07899439277755, 07899439234352
Basic UDI-DI
7899439209JC, B-07899439234352, B-07899439277755
FDA Product Code
DZC
EMDN Code
Q010405 Orthodontic wires
GMDN Term
Orthodontic wire
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.5410
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
BR-MF-000018793
Authorised representative
EC Certification Service GmbH AT-AR-000006658

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Properties

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