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Screw Open Tray Cm Ptma 26-1

by S.I.N. - Sistema DE Implante Nacional S.A. EUDAMEDGUDID

Active European Union

Ref PTMA 26-1Model LABORATORY DEVICE - CLASS I

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000048KA Basic UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995215642 UDI-DIDate21 Jul 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Screw Lab. Mt F/ Transfer. Tray Op. EUDAMED
Screw Open Tray Cm GUDID
Generic Name
Dental prosthesis/implant abutment screw analog, single-use
Device Name
Screw Laboratory
Model / Reference
PTMA 26-1, LABORATORY DEVICE - CLASS I
Primary DI / UDI-DI
07899995215642
Basic UDI-DI
999520000048KA
FDA Product Code
NDP
EMDN Code
P010299 Odontological prostheses - other
GMDN Term
Dental prosthesis/implant abutment screw analog, 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

Related devices

Category: Dental prosthesis/implant abutment screw analog, single-use

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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