Dome Bag

by Exact Medical Manufacturing, Inc China EUDAMED

Ref E5484

EMDN T030101

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697508570EC01HZ Basic UDI-DI	Date30 Dec 2021Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: E5484

Primary DI / UDI-DI: 06975085701361
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

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Properties & raw data

Show properties, registry sources and raw records

Sterile

Other properties (12)

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 1da5b13a-644c-4eae-a509-e73703a5151b 61 fields · synced 24 Oct 2026