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heracure 3D

by INNOTERE GmbH 13 variants

Ref 5220191Model Block

Active European Union

CE MDR

Valid until

1 Jun 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberIZ 1037386-1 Date8 Sep 2025IssuedStatusActive expires 1 Jun 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED

Device Name
INNOTERE 3D Scaffold
Model / Reference
Block, 5220191
Primary DI / UDI-DI
+EINN5220191
Basic UDI-DI
++EINNCPFK9C
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006515

Other devices from INNOTERE GmbH

See all devices from INNOTERE GmbH →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No