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Orthodontic Pliers

by Hangzhou DTC Medical Apparatus Co., Ltd 24 variants

Ref P105-13

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69419855DTCQZ10001AT Basic UDI-DI 06941985526403UDI-DIDate3 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06941985526403 UDI-DI Date6 Dec 2021ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Orthodontic Pliers EUDAMED
Dtc GUDID
Generic Name
Orthodontic pliers
Model / Reference
P105-13
Primary DI / UDI-DI
06941985526403 EUDAMED
06973554430798 GUDID
Basic UDI-DI
69419855DTCQZ10001AT
FDA Product Code
JEX
EMDN Code
L150702 Orthodontic pliers, reusable
GMDN Term
Orthodontic pliers
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06941985526403
GUDID
06973554430798

Manufacturer details

EUDAMED SRN
CN-MF-000032021
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Hangzhou DTC Medical Apparatus Co., Ltd

See all devices from Hangzhou DTC Medical Apparatus Co., Ltd →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No
  • Manufacturing Date: No