Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

10715-375 — Class III MDD by POLYTECH Health &…

MD Atlas
POLYTECH Health & Aesthetics GmbH

EUDAMED last updated this device on May 14, 2025

10715-375

B-04046745086219

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: POLYTECH Health & Aesthetics GmbH
UDI-DI code: 04046745086219
Reference / catalog number: 10715-375

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

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: 04046745086219
Basic UDI-DI: B-04046745086219
Reference / catalog number: 10715-375
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification