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Abtm

by AB Medical, Inc. 3 variants

Ref T60101A

Abtm (T60101A) is a device classified as IVD General made by AB Medical, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08809357962939), active as of 7 Nov 2026.

Active European Union

CE IVDD

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/IVDD NumberB-08809357962939 Basic UDI-DI Date6 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device name
ABTM 100pcs
ABTM 1200pcs
Model / reference
T60101A
Primary DI / UDI-DI
08809357962939, 08809357962946
Basic UDI-DI
B-08809357962939, B-08809357962946
EMDN code
W0104010203 Transport media
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000026779
Authorised representative
KTR Europe GmbH DE-AR-000005685

Similar devices in this category

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Other devices from AB Medical, Inc.

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Properties

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