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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

MQ-ANX-794349 — Class I MDD by Oiva Health Oy

MD Atlas
Oiva Health Oy

EUDAMED last updated this device on Jan 2, 2025

MQ-ANX-794349

B-MQ-ANX-794349-ET

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Oiva Health Oy
UDI-DI code: D-MQ-ANX-794349-ET
Reference / catalog number: MQ-ANX-794349

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Manufacturer information

Organization name: Oiva Health Oy
SRN: FI-MF-000045801
Manufacturer status: Active

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-MQ-ANX-794349-ET
Basic UDI-DI: B-MQ-ANX-794349-ET
Reference / catalog number: MQ-ANX-794349
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: —
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

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Certificates

Certificate health across this manufacturer's portfolio.

FI26/0000002Issued
Quality management systemNotified body: 0598Expiry: Jan 16, 2031