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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

Cuscino Memory 8 — Class I MDR by Bacciflex srl

MD Atlas
Bacciflex srl

EUDAMED last updated this device on May 21, 2025

Cuscino Memory 8

80519448CUSM08PT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bacciflex srl
UDI-DI code: 08051944860214
Reference / catalog number: Cuscino Memory 8

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View device family (Basic UDI)

Manufacturer information

Organization name: Bacciflex srl
SRN: IT-MF-000047829
Manufacturer status: Active

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Cuscino Memory 1080519448CUSM10PEOn the market Cuscino memory 1280519448CUSM12PJOn the market Cuscino memory 14 80519448CUSM14PNOn the market Cuscino Memory ERGO80519448CUSMERT9On the market Cuscino zenO 80519448CUSZENO3SOn 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: 08051944860214
Basic UDI-DI: 80519448CUSM08PT
Reference / catalog number: Cuscino Memory 8
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: https://www.chiardiluna.com/garanzia/
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)08051944860214

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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.

V080302PATIENT POSITIONING MEDICAL CUSHIONS

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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