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Hypodermic Needle

by Jiangsu Micsafe Medical Technology Co., Ltd 20 variants

Ref DN2812Model 28GX1/2"

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

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 NumberB-06971911293062 Basic UDI-DI 06971911293062UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971911293062 UDI-DI Date11 Jan 2022ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Hypodermic Needle EUDAMED
Micsafe GUDID
Generic Name
Hypodermic needle, single-use
Model / Reference
28GX1/2" EUDAMED
DN2812 EUDAMED
1 GUDID
Primary DI / UDI-DI
06971911293062
Basic UDI-DI
B-06971911293062
FDA Product Code
FMI, MEG, FMF
EMDN Code
A0101010102 Hypodermic syringe needles, w/o safety systems
GMDN Term
Hypodermic needle, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5570, 880.5860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
28GX1/2"
DN2812
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011594
Authorised representative
Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133

Other devices from Jiangsu Micsafe Medical Technology Co., Ltd

See all devices from Jiangsu Micsafe Medical Technology Co., Ltd →

Properties

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

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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