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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

S-1002 — IVDR Class A IVDR by Coris BioConcept

MD Atlas
Coris BioConcept

EUDAMED last updated this device on Apr 13, 2023

S-1002

54200719S10024F

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: 15420071900788
Reference / catalog number: S-1002

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Manufacturer information

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

Critical warnings

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

CW137
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW043
May cause an allergic skin reaction. May cause allergy or asthma symptoms or breathing difficulties if inhaled.
CW044
May cause genetic defects.
CW083
EUDAMED did not publish a description for this code.
CW089
EUDAMED did not publish a description for this code.
CW092
EUDAMED did not publish a description for this code.
CW106
EUDAMED did not publish a description for this code.
CW138
EUDAMED did not publish a description for this code.
CW159
EUDAMED did not publish a description for this code.
CW165
EUDAMED did not publish a description for this code.
CW166
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW171
EUDAMED did not publish a description for this code.
CW422
EUDAMED did not publish a description for this code.
CW313
EUDAMED did not publish a description for this code.
CW306
EUDAMED did not publish a description for this code.
CW401
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Oct 29, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 15420071900788
Basic UDI-DI: 54200719S10024F
Reference / catalog number: S-1002
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: ReSCape is an accessory of in vitro diagnostic devices. The reagents of the kit are intended for the rapid culture of Gram-negative bacteria collected with a rectal swab.
Additional information URL: https://www.corisbio.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010101DEHYDRATED CULTURE MEDIA (DCM)

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

RESIST-BC54200719S10014DOn 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.