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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

DONATELLO TANK_OTTIX SHAPER 4.1 LT — IVDR Class A IVDR

MD Atlas
Diapath S.p.A. società a socio unico

EUDAMED last updated this device on May 13, 2026

DONATELLO TANK_OTTIX SHAPER 4.1 LT

8033895W01030799OttixSQ7

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Diapath S.p.A. società a socio unico
UDI-DI code: 08033895009256
Reference / catalog number: H0035

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View device family (Basic UDI)

Manufacturer information

Organization name: Diapath S.p.A. società a socio unico
SRN: IT-MF-000027016
Manufacturer status: Active

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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.

CW010
EUDAMED did not publish a description for this code.
CW999
Consult Safety Data Sheet

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: DONATELLO TANK_OTTIX SHAPER 4.1 LT
UDI-DI code: 08033895009256
Basic UDI-DI: 8033895W01030799OttixSQ7
Reference / catalog number: H0035
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SOLUTION FOR USE IN COMBINATION WITH OTTIX PLUS TO REPLACE THE FULL ALCOHOL SCALE AND XYLENE
Additional information URL: https://www.diapath.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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