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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

010963 — Class I MDR by BRENTA S.R.L.

MD Atlas
BRENTA S.R.L.

EUDAMED last updated this device on Sep 3, 2024

010963

8000697FTGLEUV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BRENTA S.R.L.
UDI-DI code: 08000697031846
Reference / catalog number: 010963

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View device family (Basic UDI)

Manufacturer information

Organization name: BRENTA S.R.L.
SRN: IT-MF-000012490
Manufacturer status: Active

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0102538000697FTGNEV3On the market 0106428000697FTGNEV3On the market 010748000697FTGNEV3On the market 0106438000697FTGNEV3On the market 0102118000697FTGLEUVOn 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.
CW011
Contains latex and may cause allergic reactions in susceptible individuals

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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: 08000697031846
Basic UDI-DI: 8000697FTGLEUV
Reference / catalog number: 010963
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: 100
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 8–8.5 MU163

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08000697031846

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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.

T010201LATEX EXAMINATION / TREATMENT GLOVES

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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