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SELFINJECT 1ml with needle 25G x 1/2” (12, 7mm) U100

by CHIRANA T.Injecta, a.s.

Ref AP03-16-00Model Insulin syringe

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

CE MDR

Valid until

30 Sep 2027

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

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 Number858601504INSULIN04W7 Basic UDI-DI 08586026571189UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08586026571189 UDI-DI Date2 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2022-MDR/QS-026/D Expiring Supplemented Expires in 333 days

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    28 Nov 2025
    Expires
    30 Sep 2027
    Reason
    Other

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SELFINJECT 1ml with needle 25G x 1/2” (12,7mm) U100 EUDAMED
Selfinject GUDID
Generic Name
Insulin syringe/needle, basic
Device Name
Sterile insulin syringe for single use
Model / Ref / Catalog
Insulin syringe, AP03-16-00, U100 1ml 25G x 1/2”
Primary DI / UDI-DI
08586026571189
Basic UDI-DI
858601504INSULIN04W7
Direct Marketing DI
08586026571189
510(k) Number
FDA Product Code
FMI, FMF
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
GMDN Term
Insulin syringe/needle, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5570, 880.5860
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter
Needle Gauge — 25 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Insulin syringe
AP03-16-00
GUDID
U100 1ml 25G x 1/2”
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
SK-MF-000003702

Other devices from CHIRANA T.Injecta, a.s.

See all devices from CHIRANA T.Injecta, a.s. →

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No