Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

10053 — Class IIa MDR by Evidencio

MD Atlas
Evidencio

EUDAMED last updated this device on Nov 27, 2024

10053

8720299526410053MD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Evidencio
UDI-DI code: 08720938015144
Reference / catalog number: 10053

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?

View device family (Basic UDI)

Manufacturer information

Organization name: Evidencio
SRN: NL-MF-000008386
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Nov 18, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08720938015144
Basic UDI-DI: 8720299526410053MD
Reference / catalog number: 10053
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The OSAsense can be used to rule out the presence of obstructive sleep apnea in patients with signs and symptoms indicative of sleep apnea. The OSAsense combines and analyzes photoplethysmographic data with patient reported questionnaire data.
Additional information URL: https://evidencio.com/manuals
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08720938015144

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

Become a partner of MD Atlas

Related devices

2326872029952642326RCOn the market 2187872029952642187RNOn the market 15887202995264158XROn the market 2905872029952642905S2On the market ADNEX model87202995264946YSOn 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.