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

10010728 — Class IIa MDR by OCULUS Optikgeräte GmbH

MD Atlas
OCULUS Optikgeräte GmbH

EUDAMED last updated this device on Apr 8, 2026

10010728

40495848BQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OCULUS Optikgeräte GmbH
UDI-DI code: 04049584033574
Reference / catalog number: 10010728

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: OCULUS Optikgeräte GmbH
SRN: DE-MF-000012227
Manufacturer status: Active

Related devices

59860404958410PLOn the market 59862404958410PLOn the market 80000404958414PUOn the market C-Test Distance404958418Q4On the market C-Test, Distance visual acuity test, chart 3404958418Q4On 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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
See IFU

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
France		Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04049584033574
Basic UDI-DI: 40495848BQ
Reference / catalog number: 10010728
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12120123COMPUTERISED CORNEAL TOPOGRAPHS

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