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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

E1401OD — Class I MDR by DIFFUPLAST srl

MD Atlas
DIFFUPLAST srl

EUDAMED last updated this device on May 15, 2026

E1401OD

805815978SPYV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DIFFUPLAST srl
UDI-DI code: 18058159780594
Reference / catalog number: E1401OD

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View device family (Basic UDI)

Manufacturer information

Organization name: DIFFUPLAST srl
SRN: IT-MF-000022506
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW011
Refer to tecnichal specification for material composition before use. Do not use more than 23 gauge.

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Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 18058159780594
Basic UDI-DI: 805815978SPYV
Reference / catalog number: E1401OD
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: 125 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)18058159780594

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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.

A080102PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE

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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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.