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Amcop Bioactivator BIO-BC3M

by Micerium SpA

Ref BIO-BC3MModel Micerium AMCOP Bioactivators

Amcop Bioactivator BIO-BC3M is a Class I device made by Micerium SpA, registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI ++EMICFAM8BVW) and listed in FDA GUDID since 5 Aug 2024 (UDI-DI EMICBIOBC3M1), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EMICFAM8BVW Basic UDI-DI EMICBIOBC3M1UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICBIOBC3M1 UDI-DI Date5 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++EMICFAM8BVW registered 12 Jun 2026 Active
  • FDA GUDID UDI-DI EMICBIOBC3M1 listed 5 Aug 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EMICBIOBC3M1
  2. Registered EUDAMED ++EMICFAM8BVW

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Amcop Bioactivator
Generic name
Orthodontic retainer
Device name
Micerium AMCOP Bioactivators / Micerium AMCOP Bioactivators
Model / Ref / Catalog
BIO-BC3M, Micerium AMCOP Bioactivators
Primary DI / UDI-DI
EMICBIOBC3M1
Basic UDI-DI
++EMICFAM8BVW
FDA product code
KMY
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic retainer
Device class
Class I
Regulation number
872.5525
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic retainer

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)