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Astek 23015ASTEK3KIT

by Young Innovations, Inc.

Ref 23015ASTEK3KIT

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08403264EJI451522F Basic UDI-DI 10840326421946UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10840326421946 UDI-DI Date1 Dec 2023ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
inSafe Syringe, 2.2ml, Self Asp. Cart., Thumb Ring 3 Kit EUDAMED
Astek GUDID
Generic Name
Dental anaesthesia injection kit
Device Name
inSafe Safety Syringe System Kits
Model / Ref / Catalog
23015ASTEK3KIT
Primary DI / UDI-DI
10840326421946 EUDAMED
00840326421949 GUDID
Basic UDI-DI
08403264EJI451522F
FDA Product Code
EJI
EMDN Code
A0299 Syringes - other
GMDN Term
Dental anaesthesia injection kit
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.6770
Medical Purpose
To administer local anesthetics to designated sites during the dental procedure and to remove contaminated needle without contact
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10840326421946
GUDID
00840326421949
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Young Innovations, Inc.

See all devices from Young Innovations, Inc. →

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No