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Amnio

by M.D.L. S.r.l. Italy EUDAMED

Ref PBU2012, PBU2009, PBU2209, PBU1820, PBU2015

EMDN A01020401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08032986356552 Basic UDI-DIDate9 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PBU2012, PBU2009, PBU2209, PBU1820, PBU2015
Primary DI / UDI-DI
08032986356552, 08058341215289, 08055271571157, 08052440104017, 08032986356576
Basic UDI-DI
B-08032986356552, B-08058341215289, B-08055271571157, B-08052440104017, B-08032986356576
EMDN Code
A01020401 Amniocentesis needles and kits
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IT-MF-000011599

Other devices from M.D.L. S.R.L.

See all devices from M.D.L. S.R.L. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (5)

  • EUDAMED d37d2f8f-155b-4512-9050-d2635bab625a 61 fields · synced 22 Oct 2026
  • EUDAMED 53b3137e-48b2-48e6-91c3-481d466700bf 61 fields · synced 17 May 2026
  • EUDAMED c93b56f3-84ee-436b-9864-7e6f257ed409 61 fields · synced 17 May 2026
  • EUDAMED c4e0b843-48ee-4dfa-8c8c-1f259b2cac92 61 fields · synced 17 May 2026
  • EUDAMED 47289b59-49e5-4bbe-a66f-14558a67857f 61 fields · synced 18 May 2026