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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

010327 — Class I MDR by BRENTA S.R.L.

MD Atlas
BRENTA S.R.L.

EUDAMED last updated this device on Sep 3, 2024

010327

8000697FTGLEUV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BRENTA S.R.L.
UDI-DI code: 08000697039873
Reference / catalog number: 010327

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View device family (Basic UDI)

Manufacturer information

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

Related devices

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: 08000697039873
Basic UDI-DI: 8000697FTGLEUV
Reference / catalog number: 010327
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: 10
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 7–7.5 MU162

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.

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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