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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

Elave Baby Eczema Cream 200ml — Class I MDR by Ovelle Ltd

MD Atlas
Ovelle Ltd

EUDAMED last updated this device on May 21, 2026

Elave Baby Eczema Cream 200ml

50989281460V2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ovelle Ltd
UDI-DI code: 50989280014606S
Reference / catalog number: 1460

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Manufacturer information

Organization name: Ovelle Ltd
SRN: IE-MF-000016705
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: Elave Baby Eczema Cream 200ml
UDI-DI code: 50989280014606S
Basic UDI-DI: 50989281460V2
Reference / catalog number: 1460
Issuing entity: HIBCC

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: Elave Baby Eczema Cream 200ml
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

Elave Intensive Cream 125g50989280014456WOn the market Elave Intensive Cream 500ml50989280014516ROn the market Elave Intensive Cream 50g50989280012086EOn the market Elave Intensive Ointment50989280014406LOn the market Elave Junior Eczema Cream 200ml50989281458VFOn 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.