EUDAMED last updated this device on Jan 26, 2023

I01.01.179.001

805771751IMDCOMPONENTSJZ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: I.M.D. GENERATORS S.R.L.
UDI-DI code: 08057717510416
Reference / catalog number: I01.01.179.001

I01.01.179.001 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by I.M.D. GENERATORS S.R.L.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Jan 26, 2023

I01.01.179.001

805771751IMDCOMPONENTSJZ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: I.M.D. GENERATORS S.R.L.
UDI-DI code: 08057717510416
Reference / catalog number: I01.01.179.001

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08057717510416
Basic UDI-DI: 805771751IMDCOMPONENTSJZ
Reference / catalog number: I01.01.179.001
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: Radiology monoblock with fixed anode tube
Additional information URL: https://docs.imdxray.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)08057717510416

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.

Z11030580RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
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	Jan 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08057717510416
Basic UDI-DI: 805771751IMDCOMPONENTSJZ
Reference / catalog number: I01.01.179.001
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: Radiology monoblock with fixed anode tube
Additional information URL: https://docs.imdxray.com/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: I.M.D. GENERATORS S.R.L.
SRN: IT-MF-000027250
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08057717510416

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.

Z11030580RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
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 2402375 1Supplemented
Quality management systemNotified body: 1936Expiry: Dec 5, 2027

Certificates covering this device

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

All products by I.M.D. GENERATORS S.R.L.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2023	Still on market

I01.01.179.001

I01.01.179.001

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

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