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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

AGSS-TYPE1 — Class IIa MDR by SOL S.p.A.

MD Atlas
SOL S.p.A.

EUDAMED last updated this device on May 22, 2023

AGSS-TYPE1

805934048AGSSFH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOL S.p.A.
UDI-DI code: 08059340480128
Reference / catalog number: AGSS-TYPE1

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View device family (Basic UDI)

Manufacturer information

Organization name: SOL S.p.A.
SRN: IT-MF-000011280
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	May 16, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08059340480128
Basic UDI-DI: 805934048AGSSFH
Reference / catalog number: AGSS-TYPE1
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: AGSS type 1 - System powered by blowers
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.

Z120309MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES

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

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Certificates

Certificate health across this manufacturer's portfolio.

10000502313-PA-NoMA-ITAIssued
Quality management systemNotified body: 2460Expiry: May 16, 2028