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

050478 — Class IIb MDR by ENABLE INNOVATIONS SRL

MD Atlas
ENABLE INNOVATIONS SRL

EUDAMED last updated this device on Apr 15, 2026

050478

80540851221NP

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ENABLE INNOVATIONS SRL
UDI-DI code: 08030243038982
Reference / catalog number: 050478

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: ENABLE INNOVATIONS SRL
SRN: IT-MF-000026066
Manufacturer status: Active

Related devices

Acuvis (GOBBM-013)80540851204NPOn the market 05062680540851209NZOn the market 05057380540851201NHOn the market 05057480540851201NHOn the market Altial complete (GOLIPOM-006)80540851206NTOn the market

Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030179-00Issued
Quality management systemNotified body: 0425Expiry: Mar 22, 2031
0425-MDR-030119-01Supplemented
Quality management systemNotified body: 0425Expiry: Feb 2, 2030
0425-MDR-030020-01Supplemented
Quality management systemNotified body: 0425Expiry: Feb 26, 2028
0425-MDR-030120-00Issued
Quality management systemNotified body: 0425Expiry: Feb 2, 2030

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW275
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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 Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement	Feb 26, 2025	Feb 2, 2030

Device identification

Trade name: not provided
UDI-DI code: 08030243038982
Basic UDI-DI: 80540851221NP
Reference / catalog number: 050478
Issuing entity: GS1

Classification

Risk category: Class IIb
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

Q0299OPHTHALMIC DEVICES - OTHER

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