Secure Pack

by Promepla SAM Monaco EUDAMED

Ref OAG0005AST316 EMDN F9080

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number037005129DIA-ACC1RA Basic UDI-DI	Date20 Oct 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Secure Pack
Model / Reference: OAG0005AST316

Primary DI / UDI-DI: 03700512907169
Basic UDI-DI: 037005129DIA-ACC1RA
EMDN Code: F9080 Dialysis devices - other accessories

Device Class: Class I
Market of Registration: France

Manufacturer details

EUDAMED SRN: MC-MF-000015769
Authorised representative: Promepla Group S.à r.l. LU-AR-000013458

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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 03700512907169|037005129DIA-ACC1RA 61 fields · synced 24 Oct 2026