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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

ComeoCare v4.0 — Class I MDD by Comeo sa/nv

MD Atlas
Comeo sa/nv

EUDAMED last updated this device on May 13, 2024

ComeoCare v4.0

B-+B886CCR4000000

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Comeo sa/nv
UDI-DI code: +B886CCR4000000
Reference / catalog number: ComeoCare v4.0

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Manufacturer information

Organization name: Comeo sa/nv
SRN: BE-MF-000001651
Manufacturer status: Active

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: not provided
UDI-DI code: +B886CCR4000000
Basic UDI-DI: B-+B886CCR4000000
Reference / catalog number: ComeoCare v4.0
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.comeo.com/e-ifu
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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.