EUDAMED last updated this device on May 4, 2026

74 10 000-2; 74 12 000-2

805518667FPVP

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: A.T.S. Applicazione Tecnologie Speciali s.r.l.
UDI-DI code: 08055186671133
Reference / catalog number: 74 10 000-2; 74 12 000-2

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 4, 2026

74 10 000-2; 74 12 000-2

805518667FPVP

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: A.T.S. Applicazione Tecnologie Speciali s.r.l.
UDI-DI code: 08055186671133
Reference / catalog number: 74 10 000-2; 74 12 000-2

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08055186671133
Basic UDI-DI: 805518667FPVP
Reference / catalog number: 74 10 000-2; 74 12 000-2
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: —
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)08055186671133

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.

Z11039017MOBILE RADIOSCOPIC UNITS

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW028
Ionizing radiation max 120kV

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 5 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
EL		Still on market
Spain		Still on market
France		Still on market
XI		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055186671133
Basic UDI-DI: 805518667FPVP
Reference / catalog number: 74 10 000-2; 74 12 000-2
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: A.T.S. Applicazione Tecnologie Speciali s.r.l.
SRN: IT-MF-000010734
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055186671133

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.

Z11039017MOBILE RADIOSCOPIC UNITS

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW028
Ionizing radiation max 120kV

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 2492603 1Supplemented
Quality management systemNotified body: 1936Expiry: Dec 10, 2028

Certificates covering this device

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

Market distribution

Primary placement in Italy; available across 5 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
EL		Still on market
Spain		Still on market
France		Still on market
XI		Still on market

74 10 000-2; 74 12 000-2

74 10 000-2; 74 12 000-2

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