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

1085 Face Cushion 2 (10 Boxes/100… — Class IIa MDR

MD Atlas
Natus Medical Denmark ApS

EUDAMED last updated this device on May 6, 2026

1085 Face Cushion 2 (10 Boxes/100 Cushions)

5713315NA001014X

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Medical Denmark ApS
UDI-DI code: 05713315005862
Reference / catalog number: 8-62-62300

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: Natus Medical Denmark ApS
SRN: DK-MF-000001617
Manufacturer status: Active

Related devices

1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000885YOn the market 1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000875WOn the market

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	May 18, 2026	Dec 31, 2099

Device identification

Trade name: 1085 Face Cushion 2 (10 Boxes/100 Cushions)
UDI-DI code: 05713315005862
Basic UDI-DI: 5713315NA001014X
Reference / catalog number: 8-62-62300
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: 1085 Face Cushion 2 (10 Boxes/100 Cushions) (Class I Accessory)
Additional information URL: https://natus.com/support
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12120124VIDEO/ELECTRONYSTAGMOGRAPHS

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.