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SOL-CARE Safety Blood Collection Needle

by Sol-Millennium Medical, Inc. 4 variants

Ref SBCNS2212, 110201030035, SBCNS1912, SBCNS2107, 110201030037, SBCNS2312, SBCNS2307, SBCNS2112, SBCNS2512, 110201030034, 110201030036Model Safety Blood Collection/Infusion Butterfly Needles with Adapter, Safety Blood Collection Needle, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without), Safety Blood Collection/Infusion Butterfly Needles

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00840368501395 Basic UDI-DI Date27 Oct 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00840368501395 Basic UDI-DI Date27 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840368501395 UDI-DI Date26 Jun 2018ListedStatusListed 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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Blood collection set, invasive
Needle guard
Model / Reference
Safety Blood Collection/Infusion Butterfly Needles with Adapter, SBCNS2212, Safety Blood Collection Needle, 110201030035, SBCNS1912, SBCNS2107, 110201030034, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without), 110201030037, SBCNS2312, Safety Blood Collection/Infusion Butterfly Needles, SBCNS2307, SBCNS2112, SBCNS2512, 110201030036
Primary DI / UDI-DI
00840368501395, 10818392017301, 00840368501357, 00840368501364, 00818392017298, 00818392017304, 00810018091415, 00840368501418, 00840368501401, 00840368501371, 00840368501432, 00810018091408
Basic UDI-DI
B-00840368501395, B-10818392017301, B-00840368501357, B-00840368501364, 081006243SBC1YC, B-00840368501401, B-00840368501371, B-00840368501432, B-00840368501418
Direct Marketing DI
00810018091415
00840368501418
00818392017298
00840368501364
00818392017304
00840368501401
00840368501395
00810018091408
00840368501432
00840368501371
FDA Product Code
JKA, FPA
EMDN Code
A01010201 Butterfly needles, with safety systems
GMDN Term
Blood collection set, invasive
Needle guard
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
862.1675, 880.5440
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Length — 20 Millimeter
Needle Gauge — 25 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