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SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder

by Sol-Millennium Medical, Inc.

Ref SMSNH21125Model Safety Multi-Sample Needle (with pre-attached holder or without), Safety Multi-Sample Needle (with or without holder)

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 Number081006243SBC1YC Basic UDI-DI 00818392014952UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392014952 UDI-DI Date16 Oct 2019ListedStatusListed 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  • Withdrawn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

Generic Name
Non-fixed blood collection needle
Model / Reference
Safety Multi-Sample Needle (with pre-attached holder or without), SMSNH21125, Safety Multi-Sample Needle (with or without holder)
Primary DI / UDI-DI
00818392014952
Basic UDI-DI
081006243SBC1YC, 081006243SMS13N
Direct Marketing DI
00818392014952
FDA Product Code
FMI
EMDN Code
A01010501 Needles for collection under vacuum, with safety systems
GMDN Term
Non-fixed blood collection needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5570
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 22 Gauge
Length — 32 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No