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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

3AC461 — Class I MDR by 3A HEALTH CARE S.r.l.

MD Atlas
3A HEALTH CARE S.r.l.

EUDAMED last updated this device on Jul 12, 2023

3AC461

803371701ASP44942AN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: 3A HEALTH CARE S.r.l.
UDI-DI code: 08033717011573
Reference / catalog number: 3AC461

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Manufacturer information

Organization name: 3A HEALTH CARE S.r.l.
SRN: IT-MF-000009298
Manufacturer status: Active

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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

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 2 countries total.

Country	On market since	Until
NetherlandsPrimary placement	Jan 1, 2023	Jan 1, 2028
France	Jan 1, 2023	Jan 1, 2028

Device identification

Trade name: not provided
UDI-DI code: 08033717011573
Basic UDI-DI: 803371701ASP44942AN
Reference / catalog number: 3AC461
Issuing entity: GS1

Classification

Risk category: Class I
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.

A060399FLUID COLLECTION BAGS AND SYSTEMS - 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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