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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

10715-285 — Class III MDD by POLYTECH Health &…

MD Atlas
POLYTECH Health & Aesthetics GmbH

EUDAMED last updated this device on May 14, 2025

10715-285

B-04046745086196

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: POLYTECH Health & Aesthetics GmbH
UDI-DI code: 04046745086196
Reference / catalog number: 10715-285

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Manufacturer information

Organization name: POLYTECH Health & Aesthetics GmbH
SRN: DE-MF-000018836
Manufacturer status: Active

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40646-250B-04046745112239On the market 41647-100B-04046745112567On the market 41626-350B-04046745112321On the market 46636-550B-04046745113205On the market 15725-285B-04046745057905On 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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04046745086196
Basic UDI-DI: B-04046745086196
Reference / catalog number: 10715-285
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P0601010201BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH 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

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification