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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

163632.4 — IVDR Class A IVDR by ISOMED PHARMA, S.L.

MD Atlas
ISOMED PHARMA, S.L.

EUDAMED last updated this device on Mar 4, 2022

163632.4

8437019794GASTROKIT8Q

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ISOMED PHARMA, S.L.
UDI-DI code: 08437019794057
Reference / catalog number: 163632.4

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Manufacturer information

Organization name: ISOMED PHARMA, S.L.
SRN: ES-MF-000001341
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Dec 2, 2011	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437019794057
Basic UDI-DI: 8437019794GASTROKIT8Q
Reference / catalog number: 163632.4
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: Kit for breath samples collection for the diagnosis of small intestinal bacterial overgrowth (SIBO)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019099SAMPLES COLLECTION DEVICES - 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

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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.