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Amnio

by M.D.L. S.r.l. 12 variants

Ref PBU2018

Amnio (PBU2018) is a Class IIa device made by M.D.L. S.R.L., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-08055271576480), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08055271576480 Basic UDI-DI 08055271576480UDI-DIDate23 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
PBU2018
Primary DI / UDI-DI
08055271576480
Basic UDI-DI
B-08055271576480
EMDN code
A01020401 Amniocentesis needles and kits
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
IT-MF-000011599

Similar devices in this category

Other devices filed under BIOPSY NEEDLES AND KITS.

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

See all devices from M.D.L. S.R.L. →

Properties

  • Supplied sterile
Other properties (11, all answered No)