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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

TC55401 — IVDR Class A IVDR by Titolchimica S.p.A.

MD Atlas
Titolchimica S.p.A.

EUDAMED last updated this device on May 14, 2026

TC55401

805005413TC55401RQ

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Titolchimica S.p.A.
UDI-DI code: 08050054131092
Reference / catalog number: TC55401

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View device family (Basic UDI)

Manufacturer information

Organization name: Titolchimica S.p.A.
SRN: IT-MF-000028986
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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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: not provided
UDI-DI code: 08050054131092
Basic UDI-DI: 805005413TC55401RQ
Reference / catalog number: TC55401
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: Componenti principali TC45875 - LUGOL KIT GRAM HUCKER TC55900 - GRAM SAFRANINA TC56000 - DIFFERENZIATORE GRAM-HUCKER TC56600 - GRAM VIOLETTO CRISTALLI OSSALATO
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)08050054131092

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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.

W0104080203GRAM POSITIVE - MANUAL IDENTIFICATION
W0104080201GRAM NEGATIVE - MANUAL IDENTIFICATION

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.