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Organization name
UDI-DI code
Reference / catalog number

4HJ8 — Class I MDR by PLURITEX SRL

MD Atlas
PLURITEX SRL

EUDAMED last updated this device on Jul 1, 2022

4HJ8

805938667TTR_TELO_ABSA2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PLURITEX SRL
UDI-DI code: 08059386670347
Reference / catalog number: 4HJ8

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Manufacturer information

Organization name: PLURITEX SRL
SRN: IT-MF-000024111
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Germany		Still on market
France		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08059386670347
Basic UDI-DI: 805938667TTR_TELO_ABSA2
Reference / catalog number: 4HJ8
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

EMDN nomenclature code(s)

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

T020199SURGICAL DRAPES - OTHER

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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