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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

AI64000003 — Class IIa MDR by ALMA s.r.l.

MD Atlas
ALMA s.r.l.

EUDAMED last updated this device on May 21, 2026

AI64000003

805330089TD12AFTAC9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ALMA s.r.l.
UDI-DI code: 08053300890859
Reference / catalog number: AI64000003

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View device family (Basic UDI)

Manufacturer information

Organization name: ALMA s.r.l.
SRN: IT-MF-000029690
Manufacturer status: Active

Critical warnings

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

CW011
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.

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Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	May 12, 2025	Still on market
Portugal	May 12, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08053300890859
Basic UDI-DI: 805330089TD12AFTAC9
Reference / catalog number: AI64000003
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08053300890859

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Q0399ENT 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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Related devices

AI64000001805330089TD12AFTAC9On the market AI64000002805330089TD12AFTAC9On the market

Certificates

Certificate health across this manufacturer's portfolio.

IT342456Issued
Quality assuranceNotified body: 1370Expiry: May 11, 2030
IT342456Issued
Quality management systemNotified body: 1370Expiry: May 11, 2030