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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

GL13C14 — Class I MDR by Manifattura Falomo S.r.l.

MD Atlas
Manifattura Falomo S.r.l.

EUDAMED last updated this device on May 11, 2026

GL13C14

805360865GLAK8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Manifattura Falomo S.r.l.
UDI-DI code: 08053608658854
Reference / catalog number: GL13C14

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View device family (Basic UDI)

Manufacturer information

Organization name: Manifattura Falomo S.r.l.
SRN: IT-MF-000025751
Manufacturer status: Active

Related devices

MI1425080190805360865MIUHOn the market MI1425080195805360865MIUHOn the market MI1425080200805360865MIUHOn the market MI1425085190805360865MIUHOn the market MI1425085195805360865MIUHOn 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	Nov 30, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08053608658854
Basic UDI-DI: 805360865GLAK8
Reference / catalog number: GL13C14
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

UDI-DI DataMatrix

Encoded

(01)08053608658854

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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.

V080399MEDICAL CUSHIONS - 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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