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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

Warfarin Advisor — Class IIb MDD by Forsante Oy

MD Atlas
Forsante Oy

EUDAMED last updated this device on Nov 22, 2022

Warfarin Advisor

B-06429810731005

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Forsante Oy
UDI-DI code: 06429810731005
Reference / catalog number: Warfarin Safety Module

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Manufacturer information

Organization name: Forsante Oy
SRN: FI-MF-000008137
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Aug 31, 2015	Still on market

Device identification

Trade name: Warfarin Advisor
UDI-DI code: 06429810731005
Basic UDI-DI: B-06429810731005
Reference / catalog number: Warfarin Safety Module
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC 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

IRMA06429810731043MYOn the market PSA Follow-Up moduleB-06429810731012On the market

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.