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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

PE01 — Class I MDR by DIGI PROJECT SNC DI…

MD Atlas
DIGI PROJECT SNC DI MARIANI DANIELE E GIULIA

EUDAMED last updated this device on Nov 14, 2024

PE01

805530535PE018F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DIGI PROJECT SNC DI MARIANI DANIELE E GIULIA
UDI-DI code: 80553053500622
Reference / catalog number: PE01

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View device family (Basic UDI)

Manufacturer information

Organization name: DIGI PROJECT SNC DI MARIANI DANIELE E GIULIA
SRN: IT-MF-000044768
Manufacturer status: Active

Related devices

BP0116805530535BP0116UTOn the market F100805530535F10038On the market INP01805530535INP016UOn the market ECO01805530535ECO012WOn the market SFX1805530535SF1XBQOn 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

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

CW010
EUDAMED did not publish a description for this code.
CW273
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: 80553053500622
Basic UDI-DI: 805530535PE018F
Reference / catalog number: PE01
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)80553053500622

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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.

V0805030102ELECTRIC MOBILE LIFTS

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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