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SOL-M Oral Dispensing Syringe Amber with Tip Cap

by Sol-Millennium Medical, Inc.

Ref 20010OAModel Oral Dispensing Syringe (O-Ring type)

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
United StatesGUDID listing GUDID Number00818392011807 UDI-DI Date18 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081006243ORL638 Basic UDI-DI 00818392011807UDI-DIDate2 Oct 2024RegisteredStatusActive

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  • Withdrawn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
SOL-M Oral Dispensing Syringe Amber with Tip Cap EUDAMED
10ml Oral Syringe Amber GUDID
Generic Name
Non-ISO80369-3-standardized oral syringe, single-use
Model / Reference
Oral Dispensing Syringe (O-Ring type), 20010OA
Primary DI / UDI-DI
00818392011807
Basic UDI-DI
081006243ORL638
Direct Marketing DI
00818392011807
FDA Product Code
KYX
EMDN Code
A020199 Syringes, single-use - other
GMDN Term
Non-ISO80369-3-standardized oral syringe, single-use
Device Class
Class I
Regulation Number
880.6430
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000010890
Authorised representative
Sol-Millennium Europe Sp. z o.o. PL-AR-000010397

Other devices from Sol-Millennium Medical, Inc.

See all devices from Sol-Millennium Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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