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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

Auramine-Rhodamine Stain Kit — IVDR Class A IVDR by Delcon Srl

MD Atlas
Delcon Srl

EUDAMED last updated this device on Jun 14, 2022

Auramine-Rhodamine Stain Kit

803392853MYCOHV

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Delcon Srl
UDI-DI code: 08033928530757
Reference / catalog number: RWM2217K

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Manufacturer information

Organization name: Delcon Srl
SRN: IT-MF-000014234
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

1 warning recorded — scroll inside the panel to see all entries.

CW010
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: Auramine-Rhodamine Stain Kit
UDI-DI code: 08033928530757
Basic UDI-DI: 803392853MYCOHV
Reference / catalog number: RWM2217K
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: Auramine-Rhodamine Stain Kit is used to stain microorganisms from biological cultures or specimens in order to demonstrate the presence of mycobacteria.
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

EMDN nomenclature code(s)

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

W0104010804STAINS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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