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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

IBS101 — Class I MDR by HiDoc Technologies GmbH

MD Atlas
HiDoc Technologies GmbH

EUDAMED last updated this device on Dec 2, 2024

IBS101

426238694IBS1017L

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HiDoc Technologies GmbH
UDI-DI code: 04262386940004
Reference / catalog number: IBS101

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Manufacturer information

Organization name: HiDoc Technologies GmbH
SRN: DE-MF-000007353
Manufacturer status: —

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
1) Patient under 18 or above 70 years 2) Pregnancy

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04262386940004
Basic UDI-DI: 426238694IBS1017L
Reference / catalog number: IBS101
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The product is a stand alone Software as a medical device
Additional information URL: https://eu-prod.cara.care/uploads/Cara_Care_fuer_Reizdarm_Bedienungsanleitung_Version_14.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G99GASTROINTESTINAL DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

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.