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Impression Copings

by Southern Implants (Pty) Ltd 195 variants

Ref SFT-PRO3

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06009544053163 UDI-DIDate7 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6009544038789J Basic UDI-DIDate16 May 2024RegisteredStatusActive

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  • Withdrawn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

Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
Impression Copings
Model / Reference
SFT-PRO3
Primary DI / UDI-DI
06009544053163
Basic UDI-DI
6009544038789J
Direct Marketing DI
06009544053163
FDA Product Code
NDP
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
ZA-MF-000035362
Authorised representative
Southern Implants Europe AB SE-AR-000032508

Other devices from Southern Implants (Pty) Ltd

See all devices from Southern Implants (Pty) Ltd →

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