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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

PROMED — IVDR Class A IVDR by F.L. Medical s.r.l.…

MD Atlas
F.L. Medical s.r.l. Unipersonale

EUDAMED last updated this device on Mar 9, 2026

PROMED

8052109520003UB

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: F.L. Medical s.r.l. Unipersonale
UDI-DI code: 08052109520011
Reference / catalog number: 21202

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View device family (Basic UDI)

Manufacturer information

Organization name: F.L. Medical s.r.l. Unipersonale
SRN: IT-MF-000013918
Manufacturer status: Active

Related devices

PROMED8052109520003UBOn the market PROMEDB-08052109528642On the market PROMEDB-08055827141124On the market PROMEDB-08052109528963On the market PROMEDB-08055827141117On 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

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

CW010
EUDAMED did not publish a description for this code.

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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: PROMED
UDI-DI code: 08052109520011
Basic UDI-DI: 8052109520003UB
Reference / catalog number: 21202
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1500
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

UDI-DI DataMatrix

Encoded

(01)08052109520011

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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.

W050301020102SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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