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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

TM013-SB — IVDR Class A IVDR by Vircell, S.L

MD Atlas
Vircell, S.L

EUDAMED last updated this device on Dec 27, 2022

TM013-SB

843604032TM2015M

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Vircell, S.L
UDI-DI code: 08436040328750
Reference / catalog number: TM013-SB

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Manufacturer information

Organization name: Vircell, S.L
SRN: ES-MF-000004099
Manufacturer status: Active

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Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08436040328750
Basic UDI-DI: 843604032TM2015M
Reference / catalog number: TM013-SB
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: Transport medium for collection and transportation of saliva samples that avoids the drying up of the sample, keeps thenucleic acid integrity of the microorganism between collection and molecular analysis, and decreases bacterial overgrowth in highly contaminated samples.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

V13 112727 0005Supplemented
Quality management systemNotified body: 0123Expiry: Oct 17, 2027