EUDAMED last updated this device on Jun 5, 2026

CP253M/2

80583230DCUSTOMRD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Intersurgical SpA
UDI-DI code: 08058323005259
Reference / catalog number: CP253M/2

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Jun 5, 2026

CP253M/2

80583230DCUSTOMRD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Intersurgical SpA
UDI-DI code: 08058323005259
Reference / catalog number: CP253M/2

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08058323005259
Basic UDI-DI: 80583230DCUSTOMRD
Reference / catalog number: CP253M/2
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: CUSTOM PACK FOR NIV
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: M

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08058323005259

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

R9099RESPIRATORY AND ANAESTHESIA DEVICES - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058323005259
Basic UDI-DI: 80583230DCUSTOMRD
Reference / catalog number: CP253M/2
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: CUSTOM PACK FOR NIV
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: M

Manufacturer information

Organization name: Intersurgical SpA
SRN: IT-MF-000010729
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08058323005259

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

R9099RESPIRATORY AND ANAESTHESIA DEVICES - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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

Certificates

Certificate health across this manufacturer's portfolio.

ITH 1344699 1Supplemented
Quality management systemNotified body: 1936Expiry: Jan 24, 2028

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

CP253M/2

CP253M/2

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices