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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

STY-GEL0503 — Class III MDR by STERIFY S.R.L.

MD Atlas
STERIFY S.R.L.

EUDAMED last updated this device on Oct 11, 2023

STY-GEL0503

80593888501W4

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STERIFY S.R.L.
UDI-DI code: 08059388850037
Reference / catalog number: STY-GEL0503

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View device family (Basic UDI)

Manufacturer information

Organization name: STERIFY S.R.L.
SRN: IT-MF-000032120
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Oct 11, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08059388850037
Basic UDI-DI: 80593888501W4
Reference / catalog number: STY-GEL0503
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sterify Gel - 0.5 ml, 3 siringhe.
Additional information URL: https://www.sterify.it/IFU
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)08059388850037

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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.

P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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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Related devices

PDF-GEL0501HM80593888501W4On the market PDF-GEL1003HM80593888501W4On the market PDF-GEL1001HM80593888501W4On the market PDF-GEL0503HM80593888501W4On the market PDF-GEL0303HM80593888501W4On the market

Certificates

Certificate health across this manufacturer's portfolio.

032-00-01-MDRSupplemented
Technical documentationNotified body: 0426Expiry: Oct 5, 2028
031-00-02-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Oct 5, 2028