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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

RESIST-BC — IVDR Class A IVDR by Coris BioConcept

MD Atlas
Coris BioConcept

EUDAMED last updated this device on Nov 17, 2022

RESIST-BC

54200719S10014D

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Coris BioConcept
UDI-DI code: 15420071900764
Reference / catalog number: S-1001

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Manufacturer information

Organization name: Coris BioConcept
SRN: BE-MF-000024520
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW265
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW041
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: RESIST-BC
UDI-DI code: 15420071900764
Basic UDI-DI: 54200719S10014D
Reference / catalog number: S-1001
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: Reagents kit for blood culture CPE detection
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010599MANUAL BLOOD CULTURES - (CONCENTRATORS, ANTIBOTIC INACTIVATORS,ETC.) - 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

S-100254200719S10024FOn 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.