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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

RebiSmart 3.0 — Class IIa MDR by Ares Trading SA

MD Atlas
Ares Trading SA

EUDAMED last updated this device on Jun 4, 2024

RebiSmart 3.0

4054839RebiSmart30LE

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ares Trading SA
UDI-DI code: 04065268544877
Reference / catalog number: U6711161

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Manufacturer information

Organization name: Ares Trading SA
SRN: CH-MF-000021799
Manufacturer status: Active

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement	Nov 22, 2023	Still on market

Device identification

Trade name: RebiSmart 3.0
UDI-DI code: 04065268544877
Basic UDI-DI: 4054839RebiSmart30LE
Reference / catalog number: U6711161
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: REBISMART 3.0 AUTOINJECTOR (1)-MS-GRC
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.