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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

93578SHH — Class IIb MDD by AMO Ireland

MD Atlas
AMO Ireland

EUDAMED last updated this device on May 12, 2026

93578SHH

B-IEMF0000137040000534A

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AMO Ireland
UDI-DI code: D-IEMF0000137040000534A
Reference / catalog number: 93578SHH

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Manufacturer information

Organization name: AMO Ireland
SRN: IE-MF-000013704
Manufacturer status: Active

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93047RHB-IEMF00001370400002749On the market 94325UNB-IEMF0000137040000894XOn the market 94187CQB-IEMF0000137040000674MOn the market 94326PTB-IEMF0000137040000934NOn the market 90222GMHB-IEMF00001370400001542On the market

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement		Still on market
Croatia		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-IEMF0000137040000534A
Basic UDI-DI: B-IEMF0000137040000534A
Reference / catalog number: 93578SHH
Issuing entity: EUDAMED

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC 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)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

G10 001630 0013Issued
Quality management systemNotified body: 0123Expiry: Feb 1, 2029