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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

RiSolve — Class I MDR by Amara Therapeutics Ltd.

MD Atlas
Amara Therapeutics Ltd.

EUDAMED last updated this device on Dec 12, 2024

RiSolve

539154538OABPDTXQD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Amara Therapeutics Ltd.
UDI-DI code: 05391545380005
Reference / catalog number: PDTxA001

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Manufacturer information

Organization name: Amara Therapeutics Ltd.
SRN: IE-MF-000045497
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: RiSolve
UDI-DI code: 05391545380005
Basic UDI-DI: 539154538OABPDTXQD
Reference / catalog number: PDTxA001
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

Related devices

This device is not currently linked to any other device.

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.