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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

4007012 — Class IIb MDR by STERIS Italy S.r.l.

MD Atlas
STERIS Italy S.r.l.

EUDAMED last updated this device on May 27, 2026

4007012

8011517COLDCHEMSTERIL02MA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STERIS Italy S.r.l.
UDI-DI code: 18011517061964
Reference / catalog number: 4007012

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View device family (Basic UDI)

Manufacturer information

Organization name: STERIS Italy S.r.l.
SRN: IT-MF-000007606
Manufacturer status: Active

Related devices

500185B-18011517062404On the market 550052B-18011517061919On the market 550050B-18011517062206On the market 40081858011517COLDCHEMSTERIL02MAOn the market 40081848011517COLDCHEMSTERIL02MAOn 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

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 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Spain		Still on market

Device identification

Trade name: not provided
UDI-DI code: 18011517061964
Basic UDI-DI: 8011517COLDCHEMSTERIL02MA
Reference / catalog number: 4007012
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Adaspor Plus Pronto 1 lt, IT
Additional information URL: https://www.steris.com/
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)18011517061964

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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.

D050102PERACETIC ACID AND ADAMANTAN DERIVATIVES FOR THE DISINFECTION OF MEDICAL DEVICES

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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