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Sol-Care Safety Multi-Sample Needle

by Sol-Millennium Medical, Inc. 2 variants

Ref SMSN2115, SMSNH22125, SMSN21125, SMSNH2015, SMSNH2115Model Safety Multi-Sample Needle (with pre-attached holder or without), Safety Multi Sample Needle, Safety Multi-Sample Needle with Pre-attached Holder, Safety Multi-Sample Needle (with or without holder)

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

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/MDD EUDAMED Number081006243SBC1YC Basic UDI-DI Date29 Apr 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number081006243SBC1YC Basic UDI-DI Date29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392014679 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  • Withdrawn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/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Sol-Care Safety Multi-Sample Needle
SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder
Generic Name
Non-fixed blood collection needle
Model / Reference
Safety Multi-Sample Needle (with pre-attached holder or without), SMSN2115, SMSNH22125, Safety Multi Sample Needle, SMSN21125, SMSNH2015, SMSNH2115, Safety Multi-Sample Needle with Pre-attached Holder, Safety Multi-Sample Needle (with or without holder)
Primary DI / UDI-DI
00818392014679, 00818392014976, 00818392014662, 00818392014945, 00818392014969, 10818392014973
Basic UDI-DI
081006243SBC1YC, B-00818392014662, B-10818392014973, 081006243SMS13N
Direct Marketing DI
00818392014679
00818392014976
00818392014662
00818392014945
00818392014969
FDA Product Code
FMI
EMDN Code
A01010501, A010199
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
Length — 32 Millimeter
Needle Gauge — 21 Gauge
Needle Gauge — 22 Gauge

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