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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

FDMb037r00809019525 — Class I MDR by Frassiflex Srl

MD Atlas
Frassiflex Srl

EUDAMED last updated this device on Jun 1, 2026

FDMb037r00809019525

805894649MEMOPX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Frassiflex Srl
UDI-DI code: 08058756029006
Reference / catalog number: FDMb037r00809019525

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View device family (Basic UDI)

Manufacturer information

Organization name: Frassiflex Srl
SRN: IT-MF-000042416
Manufacturer status: Active

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.

Related devices

FDMb005r05210019025805894649MOMEMRHOn the market FDMb005r05210019525805894649MOMEMRHOn the market FDMb005r05210020025805894649MOMEMRHOn the market FDMb005r05211019025805894649MOMEMRHOn the market FDMb005r05211019525805894649MOMEMRHOn the market

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	Apr 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058756029006
Basic UDI-DI: 805894649MEMOPX
Reference / catalog number: FDMb037r00809019525
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)08058756029006

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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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