Monouso Standard

by BENEFIS S.r.l. 86 variants

Ref 0621NSS 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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number805299200MTMTNT0205H9 Basic UDI-DI 08052992010712UDI-DI	Date5 Nov 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Withdrawn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

Model / reference: 0621NSS B

Primary DI / UDI-DI: 08052992010712
Basic UDI-DI: 805299200MTMTNT0205H9
EMDN code: T0205 Non-surgical gowns (excluding personal protective equipment - PPE)

Device class: Class I
EU registration type: Standard device
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: IT-MF-000022530

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Properties

Other properties (14)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Reusable: No
Contains latex: No
Reprocessed single-use device: No
Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
Incorporates a substance derived from human blood or plasma: No
Contains human tissues or cells: No
Contains animal tissues or cells: No
Contains endocrine-disrupting substances: No
Administering medicine: No
Measuring function: No
Incorporates a medicinal substance: No