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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

EM1100CA — Class I MDR by SOL GROUP LAB S.r.l.

MD Atlas
SOL GROUP LAB S.r.l.

EUDAMED last updated this device on Aug 28, 2025

EM1100CA

805571326TROLLEYZF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOL GROUP LAB S.r.l.
UDI-DI code: 08055713260236
Reference / catalog number: EM1100CA

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View device family (Basic UDI)

Manufacturer information

Organization name: SOL GROUP LAB S.r.l.
SRN: IT-MF-000025276
Manufacturer status: Active

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.
CW257
EUDAMED did not publish a description for this code.

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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: not provided
UDI-DI code: 08055713260236
Basic UDI-DI: 805571326TROLLEYZF
Reference / catalog number: EM1100CA
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

UDI-DI DataMatrix

Encoded

(01)08055713260236

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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.

Z1203019002NITRIC OXIDE DISPENSERS

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

Certificate health across this manufacturer's portfolio.

0425-MDR-030142-00Issued
Quality management systemNotified body: 0425Expiry: Jul 31, 2030