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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

DSA1005 — Class IIa MDR by XENODERM S.R.L.

MD Atlas
XENODERM S.R.L.

EUDAMED last updated this device on May 19, 2023

DSA1005

805609809DSA1005CD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: XENODERM S.R.L.
UDI-DI code: 08056098090050
Reference / catalog number: DSA1005

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View device family (Basic UDI)

Manufacturer information

Organization name: XENODERM S.R.L.
SRN: IT-MF-000031000
Manufacturer status: Active

Related devices

GPX1010B-80560980927262On the market DENSITY PLATELET GEL805609809GPX1001LEOn the market GPX1201B-80556098091552VNOn the market GPX1001B-805609809013553On the market DGA10018056098090029DAG1001ELOn 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.

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056098090050
Basic UDI-DI: 805609809DSA1005CD
Reference / catalog number: DSA1005
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: DISINFETTANTE A BASE DI SALI DI AMMONIO QUATERNARIO PER LA STERILIZZAZIONE DI DISPOSITIVI MEDICI
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)08056098090050

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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.

D0901AMMONIUM SALTS FOR THE DISINFECTION OF MEDICAL DEVICES

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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