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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

Heart E-2,8 — Class I MDR by Pletra Ltd.

MD Atlas
Pletra Ltd.

EUDAMED last updated this device on May 23, 2026

Heart E-2,8

477904381EXOBREASTZ3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pletra Ltd.
UDI-DI code: 04779043811350
Reference / catalog number: Heart E-2,8

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View device family (Basic UDI)

Manufacturer information

Organization name: Pletra Ltd.
SRN: LT-MF-000004741
Manufacturer status: Active

Related devices

Oval A-6477904381EXOBREASTZ3On the market Oval A-5477904381EXOBREASTZ3On the market Heart E-9,5477904381EXOBREASTZ3On the market Triangle F-2477904381EXOBREASTZ3On the market Triangle F-1477904381EXOBREASTZ3On 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Lithuania; available across 1 country total.

Country	On market since	Until
LithuaniaPrimary placement	May 1, 2004	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04779043811350
Basic UDI-DI: 477904381EXOBREASTZ3
Reference / catalog number: Heart E-2,8
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: External silicone gel breast prosthesis for compensation after mastectomy or breast asymmetry
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04779043811350

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y063018EXTERNAL BREAST PROSTHESES

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

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