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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

SAFECAPSULE – FORMALIN AND MARKER… — IVDR Class A IVDR

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

EUDAMED last updated this device on May 8, 2026

SAFECAPSULE – FORMALIN AND MARKER (19 ML) 36 PCS

8033895W01030705SafCap2X

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: 08033895011013
Reference / catalog number: SC042E

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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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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: SAFECAPSULE – FORMALIN AND MARKER (19 ML) 36 PCS
UDI-DI code: 08033895011013
Basic UDI-DI: 8033895W01030705SafCap2X
Reference / catalog number: SC042E
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: The devices is a red safety capsule containing formaldehyde and marker. The device is intended for use in combination with the transparent container, containing buffered neutral solution (REF: SC041)
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

UDI-DI DataMatrix

Encoded

(01)08033895011013

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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.

W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.