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Test Tubes, Micro 101521

by Bio/Data Corporation

Ref 101521

Test Tubes, Micro 101521 is a device classified as Class A in the EU and Class I in the US made by Bio/Data Corporation, registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI ++G0561015213G) and listed in FDA GUDID since 30 Aug 2023 (UDI-DI *+G0561015211/ $$676XXXXX/ 16D20000101F*), active as of 25 Oct 2026.

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

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++G0561015213G Basic UDI-DI *+G0561015211/ $$676XXXXX/ 16D20000101F*UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number*+G0561015211/ $$676XXXXX/ 16D20000101F* UDI-DI Date30 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++G0561015213G registered 1 Jun 2026 Active
  • FDA GUDID UDI-DI *+G0561015211/ $$676XXXXX/ 16D20000101F* listed 30 Aug 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID *+G0561015211/ $$676XXXXX/ 16D20000101F*
  2. Registered EUDAMED ++G0561015213G

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Micro Test Tubes EUDAMED
Test Tubes, Micro GUDID
Generic name
Assay container IVD, single-use
Model / Ref / Catalog
101521
Primary DI / UDI-DI
*+G0561015211/ $$676XXXXX/ 16D20000101F* EUDAMED
G0561015211 GUDID
Basic UDI-DI
++G0561015213G
FDA product code
GLE
EMDN code
W0503010102 Samples analyses, glass cuvettes
GMDN term
Assay container IVD, single-use
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2050
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
*+G0561015211/ $$676XXXXX/ 16D20000101F*
GUDID
G0561015211
Device classEUDAMED
Class A
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists *+G0561015211/ $$676XXXXX/ 16D20000101F*; FDA GUDID lists G0561015211), so their flags are not compared. Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Assay container IVD, single-use

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Other devices filed under ANALYSIS CONTAINERS.

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Properties

  • Single use
  • Professional testing
  • Companion diagnostics
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)