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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

Amiko_on_Ellipta — Class I MDR by AMIKO SRL

MD Atlas
AMIKO SRL

EUDAMED last updated this device on Jun 12, 2023

Amiko_on_Ellipta

805572743RESPIROSENSUS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AMIKO SRL
UDI-DI code: 08055727430007
Reference / catalog number: Amiko_on_Ellipta

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View device family (Basic UDI)

Manufacturer information

Organization name: AMIKO SRL
SRN: IT-MF-000010697
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: Amiko_on_Ellipta
UDI-DI code: 08055727430007
Basic UDI-DI: 805572743RESPIROSENSUS
Reference / catalog number: Amiko_on_Ellipta
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: AMIKO_ON_ELLIPTA is a case for drug inhalers, equipped with sensors for the detection of the inhalation for the subsequent evaluation of the inhalation by the patient and the prescribing physician.
Additional information URL: https://amiko.io/
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)08055727430007

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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.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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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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.