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Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills

by Medigma Biomedical GmbH EUDAMEDGUDID

Active European Union and United States

Ref SURPAS, RS6324, SURPAModel Dental Drill, Kit, Tools

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-DEMF000009412SURPAS4Y Basic UDI-DIDate16 Jun 2022RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-DEMF000009412SURPAS4Y Basic UDI-DIDate16 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-DEMF000009412SURPAS4Y UDI-DIDate23 Apr 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD 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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills EUDAMED
RS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills EUDAMEDGUDID
Standard Internal Hex Plastic Surgical Kit-Advanced EUDAMED
Generic Name
Dental implant/prosthesis surgical procedure kit
Device Name
Dental Drill
Tools
Model / Reference
Dental Drill, SURPAS, Kit, RS6324, Tools, SURPA
Primary DI / UDI-DI
D-DEMF000009412SURPAS4Y, 07290105156372, D-DEMF000009412SURPABT, 04260525162829
Basic UDI-DI
B-DEMF000009412SURPAS4Y, 729010515FullKitHE, B-DEMF000009412SURPABT, 426052516FullKitFK
FDA Product Code
OFY
EMDN Code
Z12110102, L159016, Z12110180
GMDN Term
Dental implant/prosthesis surgical procedure kit
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
Market of Registration
Türkiye
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000009412

Other devices from Medigma Biomedical GmbH

See all devices from Medigma Biomedical GmbH →

Properties

  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No