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SOL-CARE Safety Blood Collection Needle with Pre-attached Holder

by Sol-Millennium Medical, Inc. 2 variants

Ref 110201030008, 110201030004Model Safety Blood Collection/Infusion Butterfly Needles with Holder, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)

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/MDR EUDAMED NumberB-00818392015614 Basic UDI-DI Date8 Jan 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00818392015614 Basic UDI-DI Date8 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00818392015614 UDI-DI Date23 Oct 2017ListedStatusListed 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  • Withdrawn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

Trade Name
SOL-CARE Safety Blood Collection Needle with Pre-attached Holder EUDAMED
SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder GUDID
Generic Name
Needle guard
Model / Reference
Safety Blood Collection/Infusion Butterfly Needles with Holder, 110201030008, 110201030004, Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)
Primary DI / UDI-DI
00818392015614, 00818392015591
Basic UDI-DI
B-00818392015614, B-00818392015591, 081006243SBC1YC
Direct Marketing DI
00818392015591
00818392015614
FDA Product Code
JKA
EMDN Code
A01010201 Butterfly needles, with safety systems
GMDN Term
Needle guard
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
862.1675
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 21 Gauge
Length — 20 Millimeter
Needle Gauge — 23 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