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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

EIPL-PRD-K01 — Class IIb MDD by CLARTEIS SAS

MD Atlas
CLARTEIS SAS

EUDAMED last updated this device on Nov 22, 2022

EIPL-PRD-K01

B-EIPL-100FH

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: CLARTEIS SAS
UDI-DI code: D-EIPL-100FH
Reference / catalog number: EIPL-PRD-K01

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Manufacturer information

Organization name: CLARTEIS SAS
SRN: FR-MF-000002542
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Nov 15, 2016	Still on market
Czechia	Nov 16, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-EIPL-100FH
Basic UDI-DI: B-EIPL-100FH
Reference / catalog number: EIPL-PRD-K01
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040202PHOTOTHERAPY EQUIPMENT

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

EIPL-PRD-K01-8376031346EIPL-100DBOn 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.