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ApicalShaper sterile files

by Shenzhen Denco Medical Co., Ltd. 4 variants

Ref ZAS3103003Model ApicalShaper sterile files 31mm Z30/03 (6 units)

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 NumberB-06975718050606 Basic UDI-DI 06975718050606UDI-DIDate26 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975718050606 UDI-DI Date8 Aug 2023ListedStatusListed GUDID: not 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  • Withdrawn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
ApicalShaper sterile files EUDAMED
Avalon Biomed GUDID
Generic Name
Manual endodontic file/rasp, single-use
Model / Reference
ApicalShaper sterile files 31mm Z30/03 (6 units) EUDAMED
ZAS3103003 EUDAMED
ApicalShaper sterile 31mm Z30/03 GUDID
Primary DI / UDI-DI
06975718050606
Basic UDI-DI
B-06975718050606
FDA Product Code
EKS
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
GMDN Term
Manual endodontic file/rasp, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
EU market of registration
Spain
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ApicalShaper sterile files 31mm Z30/03 (6 units)
ZAS3103003
GUDID
ApicalShaper sterile 31mm Z30/03
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000014271
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Shenzhen Denco Medical Co., Ltd.

See all devices from Shenzhen Denco Medical Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Manufacturing Date: No