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5ml Plastic Syringe 201

by Ultradent Products, Inc.

Ref 201

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, 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 Number0883205-TF044AX Basic UDI-DI 00883205019400UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205019400 UDI-DI Date13 Jun 2018ListedStatusListed GUDID: 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  • Withdrawn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
Ultradent 5ml Syringes EUDAMED
5ml Plastic Syringe GUDID
Generic Name
General-purpose syringe, single-use
Device Name
Syringes
Model / Ref / Catalog
201
Primary DI / UDI-DI
00883205019400
Basic UDI-DI
0883205-TF044AX
FDA Product Code
EIC
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
General-purpose syringe, single-use
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose syringe, single-use

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No