Bolus

by BolusCare UG (haftungsbeschränkt)

Ref BC-0030-A/B

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

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number42559695BCD2026C3 Basic UDI-DI 04255969500177UDI-DI	Date15 Jul 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Bolus
Model / Reference: BC-0030-A/B

Primary DI / UDI-DI: 04255969500177
Basic UDI-DI: 42559695BCD2026C3
EMDN Code: V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: DE-MF-000056518

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Properties

Reprocessed

Other properties (12)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: 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