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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

FRE0402 — Class I MDR by FIOCCHETTI SCIENTIFIC…

MD Atlas
FIOCCHETTI SCIENTIFIC S.R.L.

EUDAMED last updated this device on Feb 6, 2025

FRE0402

805825347FDLLL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FIOCCHETTI SCIENTIFIC S.R.L.
UDI-DI code: 08058253471063
Reference / catalog number: FRE0402

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View device family (Basic UDI)

Manufacturer information

Organization name: FIOCCHETTI SCIENTIFIC S.R.L.
SRN: IT-MF-000011566
Manufacturer status: Active

Critical warnings

7 warnings recorded — scroll inside the panel to see all entries.

CW273
Leggere attentamente il Manuale Utente prima di utilizzare il dispositivo
CW010
Leggere attentamente il Manuale Utente prima di utilizzare il dispositivo
CW007
EUDAMED did not publish a description for this code.
CW053
Il gas refrigerante utilizzato è infiammabile ( Vedi Manuale Utente)
CW136
Leggere l'etichetta sull'imballo
CW135
Leggere attentamente il Manuale Utente prima di utilizzare il dispositivo
CW138
Leggere attentamente il Manuale Utente prima di utilizzare il dispositivo

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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: 08058253471063
Basic UDI-DI: 805825347FDLLL
Reference / catalog number: FRE0402
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: Refrigerator destined to store and preserve vaccines, pharmaceutical products, bacterial cultures, samples, analysis materials, chemical products, and other laboratory formulas, to support therapy and/or prevention in clinical centers, hospitals, pharmacies, and laboratories.
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

UDI-DI DataMatrix

Encoded

(01)08058253471063

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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.

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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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.