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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

ESPF/XS — Class I MDR by ICOGUANTI S.p.A.

MD Atlas
ICOGUANTI S.p.A.

EUDAMED last updated this device on May 18, 2026

ESPF/XS

8005830GLPFYN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ICOGUANTI S.p.A.
UDI-DI code: 08005830002196
Reference / catalog number: ESPF/XS

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View device family (Basic UDI)

Manufacturer information

Organization name: ICOGUANTI S.p.A.
SRN: IT-MF-000053804
Manufacturer status: Active

Related devices

HCN/L8005830GNPFYYOn the market HCN/M8005830GNPFYYOn the market HCN/S8005830GNPFYYOn the market ENPF/XS8005830GNPFYYOn the market ESMS/L8005830GLPPZAOn the market

Critical warnings

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

CW129
Contiene lattice di gomma naturale che può causare reazioni allergiche compreso lo shock anafilattico. Contiene potenziali allergeni che possono causare allergie di tipo IV.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 9, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08005830002196
Basic UDI-DI: 8005830GLPFYN
Reference / catalog number: ESPF/XS
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: Guanto Medicale Monouso da Esame a base di lattice di gomma naturale, senza polvere non sterile.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 240–250 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08005830002196

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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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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.