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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

Drug Safety System — Class I MDD by Synapse medicine

MD Atlas
Synapse medicine

EUDAMED last updated this device on Sep 25, 2023

Drug Safety System

B-DrugSafetySystemLA

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Synapse medicine
UDI-DI code: D-DrugSafetySystemLA
Reference / catalog number: Drug Safety System

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Manufacturer information

Organization name: Synapse medicine
SRN: FR-MF-000009699
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-DrugSafetySystemLA
Basic UDI-DI: B-DrugSafetySystemLA
Reference / catalog number: Drug Safety System
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The software system enables alerts to be generated in relation to: physio-pathological terrain or patient environment variables, drug-indexed decision support systems, drug interactions, physico-chemical incompatibilities, redundancy of active substances, adverse effects, dosage data.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040282GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES

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.