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Dctaperh Rotary File 30/V06 L31

by Micro Mega

Ref 21356-DSModel DCTAPERH ROTARY FILE

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

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-++J01521356-DS1 Basic UDI-DI ++J01521356-DS1UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number++J01521356-DS1 UDI-DI Date24 Feb 2026ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Dctaperh Rotary File
Generic Name
Rotary/reciprocating endodontic file/rasp, single-use
Model / Ref / Catalog
DCTAPERH ROTARY FILE, 21356-DS, 30/V06 L31
Primary DI / UDI-DI
++J01521356-DS1 EUDAMED
J01521356DS1 GUDID
Basic UDI-DI
B-++J01521356-DS1
FDA Product Code
EKS
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
GMDN Term
Rotary/reciprocating endodontic file/rasp, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DCTAPERH ROTARY FILE
21356-DS
GUDID
30/V06 L31
Primary DI / UDI-DIEUDAMED
++J01521356-DS1
GUDID
J01521356DS1
Device ClassEUDAMED
Class IIa
GUDID
Class I

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Properties

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

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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
  • Expiration Date: No