Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

MQ-CVD-922192 — Class I MDD by Oiva Health Oy

MD Atlas
Oiva Health Oy

EUDAMED last updated this device on Jan 2, 2025

MQ-CVD-922192

B-MQ-CVD-922192-6U

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Oiva Health Oy
UDI-DI code: D-MQ-CVD-922192-6U
Reference / catalog number: MQ-CVD-922192

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

SCREENINGTOOL6429811363SCREENINGTOOL29On the market MQ-ANX-794349B-MQ-ANX-794349-ETOn the market MQ-DEPR-425515B-MQ-DEPR-425515-RYOn the market MQ-DEPR-786568B-MQ-DEPR-786568-XEOn the market MQ-DEPR-181416B-MQ-DEPR-181416-RBOn the market

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-CVD-922192-6U
Basic UDI-DI: B-MQ-CVD-922192-6U
Reference / catalog number: MQ-CVD-922192
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

Certificates

Certificate health across this manufacturer's portfolio.

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