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Dome Bag

by Exact Medical Manufacturing, Inc China EUDAMED

Ref EDB22N

EMDN T030101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697508570EC01HZ Basic UDI-DIDate30 Dec 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
EDB22N
Primary DI / UDI-DI
06975085703112
Basic UDI-DI
697508570EC01HZ
EMDN Code
T030101 Cover caps, instruments and equipment
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000001406
Authorised representative
Exact Medical Manufacturing B.V. NL-AR-000000452

Other devices from Exact Medical Manufacturing, Inc

See all devices from Exact Medical Manufacturing, Inc →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED ecd58718-d1a6-40a1-bdec-3c964ca23855 61 fields · synced 22 Oct 2026