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

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Organization name
UDI-DI code
Reference / catalog number

050400 — Class IIb MDR by ENABLE INNOVATIONS SRL

MD Atlas
ENABLE INNOVATIONS SRL

EUDAMED last updated this device on Apr 21, 2026

050400

80540851202NK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ENABLE INNOVATIONS SRL
UDI-DI code: 08054085121404
Reference / catalog number: 050400

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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.

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

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Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	Feb 13, 2024	Feb 26, 2028

Device identification

Trade name: not provided
UDI-DI code: 08054085121404
Basic UDI-DI: 80540851202NK
Reference / catalog number: 050400
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

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