Skip to content

copaSKY

by bredent medical GmbH & Co. KG 11 variants

Ref copa4512, copa3510, copa4010, copa5010, copa3508, copa4008, copa4014, copa5005, copa3514, copa3010, copa3008, copa4505, copa6005, copa4508Model Dental implants, titanium

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EBRM2bSKYImp62 Basic UDI-DI Date19 Nov 2025RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Dental implants, titanium, copa4512, copa3510, copa4010, copa5010, copa3508, copa4008, copa4014, copa5005, copa3514, copa3010, copa3008, copa4505, copa6005, copa4508
Primary DI / UDI-DI
+EBRMCOPA45120Q, +EBRMCOPA35100N, +EBRMCOPA40100J, +EBRMCOPA50100K, +EBRMCOPA35080U, +EBRMCOPA40080Q, +EBRMCOPA40140N, +EBRMCOPA50050O, +EBRMCOPA35140R, +EBRMCOPA30100I, +EBRMCOPA30080P, +EBRMCOPA45050S, +EBRMCOPA60050P, +EBRMCOPA45080V
Basic UDI-DI
++EBRM2bSKYImp62
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008125

Other devices from bredent medical GmbH & Co. KG

See all devices from bredent medical GmbH & Co. KG →

Properties

  • Sterile
  • Implantable
  • Sutures

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