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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

BTSU/Y NERO — Class I MDR by Firsystem S.r.l.

MD Atlas
Firsystem S.r.l.

EUDAMED last updated this device on May 13, 2026

BTSU/Y NERO

805681453INDUMENTIFIRGM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Firsystem S.r.l.
UDI-DI code: 08056814531553
Reference / catalog number: BTSU/Y NERO

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View device family (Basic UDI)

Manufacturer information

Organization name: Firsystem S.r.l.
SRN: IT-MF-000039213
Manufacturer status: Active

Related devices

BCAND/L/XL BIANCO805681453INDUMENTIFIRGMOn the market BCAND/L/XL NERO805681453INDUMENTIFIRGMOn the market BCAND/S/M BIANCO805681453INDUMENTIFIRGMOn the market BCAND/S/M NERO805681453INDUMENTIFIRGMOn the market BCAND/XXL BIANCO805681453INDUMENTIFIRGMOn 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

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056814531553
Basic UDI-DI: 805681453INDUMENTIFIRGM
Reference / catalog number: BTSU/Y NERO
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: Y

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08056814531553

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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.

Y090699DEVICES FOR BODY PROTECTION - OTHER

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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