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Amcop Bioactivator BTC2-DCM

by Micerium SpA

Ref BTC2-DCMModel Micerium AMCOP Bioactivators

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EMICFAM8BVW Basic UDI-DI EMICBTC2DCM1UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICBTC2DCM1 UDI-DI Date27 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
BTC2-DCM, Micerium AMCOP Bioactivators
Primary DI / UDI-DI
EMICBTC2DCM1
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

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (22)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No