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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

NE-C101-ITA — Class IIa 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

NE-C101-ITA

803371701NEB354574R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: 3A HEALTH CARE S.r.l.
UDI-DI code: 04015672111080
Reference / catalog number: NE-C101-ITA

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View device family (Basic UDI)

Manufacturer information

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

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NE-C300-EB-04015672109407On the market NE-C300-ITAB-04015672109674On the market NEB6001B-04015672109681On the market NEB5006B-04015672109704On the market NEB6020803371701NEB6204244On the market

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 Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2023	Jan 1, 2028

Device identification

Trade name: not provided
UDI-DI code: 04015672111080
Basic UDI-DI: 803371701NEB354574R
Reference / catalog number: NE-C101-ITA
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

EMDN nomenclature code(s)

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

Z12159099VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - 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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