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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

BLUE SOFT — Class I MDR by UGOFLEX MANUFACTORY SRL

MD Atlas
UGOFLEX MANUFACTORY SRL

EUDAMED last updated this device on Mar 3, 2026

BLUE SOFT

805571561BLUESOFT5S

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UGOFLEX MANUFACTORY SRL
UDI-DI code: 08055715610053
Reference / catalog number: BLUE SOFT

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View device family (Basic UDI)

Manufacturer information

Organization name: UGOFLEX MANUFACTORY SRL
SRN: IT-MF-000047522
Manufacturer status: Active

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ANNECY805571561ANNECYDAOn the market ATHENA805571561ATHENADKOn the market AXIMA FIRM805571561AXIMAFIRMJ2On the market AXIMA SOFT805571561AXIMASOFTM5On the market BLUE FIRM805571561BLUEFIRM2POn 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.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08055715610053
Basic UDI-DI: 805571561BLUESOFT5S
Reference / catalog number: BLUE SOFT
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: No clinical sizes registered for this device.

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.

V0899MEDICAL SUPPORT EQUIPMENT - 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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