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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

CL-01 — Class I MDD by Orteam BV

MD Atlas
Orteam BV

EUDAMED last updated this device on May 20, 2026

CL-01

B-CL-01R4

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Orteam BV
UDI-DI code: D-CL-01R4
Reference / catalog number: CL-01

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Manufacturer information

Organization name: Orteam BV
SRN: BE-MF-000054350
Manufacturer status: Active

Critical warnings

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

CW010
Het hulpmiddel moet gebruikt worden volgens de instructies van de fabrikant en, indien van toepassing, onder toezicht van een zorgprofessional. Onjuist gebruik of foutieve positionering kan leiden tot discomfort of een slechte zithouding. Het hulpmiddel mag niet gebruikt worden indien het beschadigd is.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Jan 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-CL-01R4
Basic UDI-DI: B-CL-01R4
Reference / catalog number: CL-01
Issuing entity: EUDAMED

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: De ORTEAM Clawieter aangepaste kinderstoel is een positioneringshulpmiddel voor kinderen en kan gecombineerd worden met aanvullende ondersteuningscomponenten, waaronder maatwerkvoorzieningen zoals rugschelpen.
Additional information URL: https://www.vaph.be/hulpmiddelen/databank/orteam-clawieter-aangepaste-kinderstoel
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y180918MULTIFUNCTIONAL CHAIRS

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

BB-01B-BB-01NKOn the market VT-01B-VT-01ZDOn 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.