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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

TM230 — IVDR Class A IVDR by DIAGNOTIS SAS

MD Atlas
DIAGNOTIS SAS

EUDAMED last updated this device on Feb 13, 2024

TM230

3770032939TM230Y2

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DIAGNOTIS SAS
UDI-DI code: 03770032939049
Reference / catalog number: TM230

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Manufacturer information

Organization name: DIAGNOTIS SAS
SRN: FR-MF-000035861
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 03770032939049
Basic UDI-DI: 3770032939TM230Y2
Reference / catalog number: TM230
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: MYCOPROSAFE (MPS)® est un kit de décontamination et de concentration des échantillons. Il permet le traitement des échantillons cliniques pour la microscopie, la culture et les méthodes moléculaires d’identification et d’isolement des mycobactéries.
Additional information URL: https://www.diagnotis.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010799MYCOBACTERIA REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

DCC0513770032939DCC051S6On the market DECOCENT3770032939DCC050S4On the market DECOMICS3770032939DEC010SEOn the market MPS2303770032939MPS2305XOn the market TM2403770032939TM240Y5On 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.