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Bk-01

by Medi̇kal 2000 Tibbi̇ Ci̇hazlar Ve İleri̇ Teknoloji̇ San. Ve Ti̇c. A.Ş.

Ref BK-01

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, self-declared

Class I: no certifier involved

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 Number86976015BK-01MC Basic UDI-DI 08697601522837UDI-DIDate20 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Bk-01 Baby Cot
Model / Reference
BK-01
Primary DI / UDI-DI
08697601522837
Basic UDI-DI
86976015BK-01MC
EMDN Code
V0809 Manual clinical cribs for newborns
Device Class
Class I
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
TR-MF-000019533

Other devices from Medi̇kal 2000 Tibbi̇ Ci̇hazlar Ve İleri̇ Teknoloji̇ San. Ve Ti̇c. A.Ş.

See all devices from Medi̇kal 2000 Tibbi̇ Ci̇hazlar Ve İleri̇ Teknoloji̇ San. Ve Ti̇c. A.Ş. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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