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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

2.0 — Class I MDD by ADESANTE Oy

MD Atlas
ADESANTE Oy

EUDAMED last updated this device on Dec 15, 2021

2.0

B-SurgeryVision6S

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ADESANTE Oy
UDI-DI code: D-SurgeryVision6S
Reference / catalog number: 2.0

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Manufacturer information

Organization name: ADESANTE Oy
SRN: FI-MF-000015682
Manufacturer status: Active

Related devices

This device is not currently linked to any other device.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-SurgeryVision6S
Basic UDI-DI: B-SurgeryVision6S
Reference / catalog number: 2.0
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: SurgeryVision is a medical image viewer, which presents MRI/CT scans in 3D stereoscopic format by utilizing Extended reality (XR) technology.
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

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.