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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

FIX09NBSP — Class I MDR by RAYS S.p.A.

MD Atlas
RAYS S.p.A.

EUDAMED last updated this device on Dec 20, 2024

FIX09NBSP

805621138PlastersLW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RAYS S.p.A.
UDI-DI code: 80570141830300
Reference / catalog number: FIX09NBSP

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View device family (Basic UDI)

Manufacturer information

Organization name: RAYS S.p.A.
SRN: IT-MF-000009229
Manufacturer status: Active

Related devices

FIT03NBSC805621138PlastersLWOn the market FIT05NTSD805621138PlastersLWOn the market FIX11NBSP805621138PlastersLWOn the market FIX10NBSP805621138PlastersLWOn the market FIX08NBSP805621138PlastersLWOn 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

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

CW009
EUDAMED did not publish a description for this code.
CW007
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: not provided
UDI-DI code: 80570141830300
Basic UDI-DI: 805621138PlastersLW
Reference / catalog number: FIX09NBSP
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)80570141830300

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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.

M050201EXTENSIBLE NON-WOVEN PLASTERS

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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