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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

Monobloc(r) - Silicone SoftOne(r) — Class III MDD

MD Atlas
LABORATOIRES ARION

EUDAMED last updated this device on May 26, 2026

Monobloc(r) - Silicone SoftOne(r)

B-03760136510480

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABORATOIRES ARION
UDI-DI code: 03760136510480
Reference / catalog number: GS-A2X295-MT

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View device family (Basic UDI)

Manufacturer information

Organization name: LABORATOIRES ARION
SRN: FR-MF-000025697
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Oct 11, 2002	Still on market

Device identification

Trade name: Monobloc(r) - Silicone SoftOne(r)
UDI-DI code: 03760136510480
Basic UDI-DI: B-03760136510480
Reference / catalog number: GS-A2X295-MT
Issuing entity: GS1

Classification

Risk category: Class III
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: 295 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03760136510480

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EMDN nomenclature code(s)

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

P0601020202BREAST IMPLANTS, ANATOMICAL, MADE OF SILICONE, WITH TEXTURED SURFACE

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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Related devices

Monobloc(r) - Silicone SoftOne(r)B-03760136510466On the market Monobloc(r) Silicone SoftOne(r)B-03760136515539On the market Monobloc(r) Silicone SoftOne(r)B-03760136510503On the market Monobloc(r) Silicone SoftOne(r)B-03760136510527On the market Monobloc(r) Silicone SoftOne(r)B-03760136515799On 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.