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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

EI GU2 0008 004 — Class I MDR by ELESTA SpA

MD Atlas
ELESTA SpA

EUDAMED last updated this device on Sep 13, 2024

EI GU2 0008 004

805228659EIGU20008xxx4Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ELESTA SpA
UDI-DI code: 08052286590265
Reference / catalog number: EI GU2 0008 004

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View device family (Basic UDI)

Manufacturer information

Organization name: ELESTA SpA
SRN: IT-MF-000037909
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Not sterile. To be sterilized before use.

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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: 08052286590265
Basic UDI-DI: 805228659EIGU20008xxx4Y
Reference / catalog number: EI GU2 0008 004
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)08052286590265

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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.

A018002NEEDLE GUIDES

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

Certificate health across this manufacturer's portfolio.

IT343885Issued
Quality management systemNotified body: 1370Expiry: Jul 8, 2030