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Breast expander

by POLYTECH Health & Aesthetics GmbH 231 variants

Ref 61637-200, 46627-200, 66657-400, 46626-450, 46637-500, 61627-800, 40647-500, 66637-400, 66677-200, 60627-800, 46627-500, 61646-450, 66636-550, 41627-400, 46647-500, 66647-600, 40647-200, 61637-600, 61627-100, 61637-400, 66637-500, 61647-300, 40637-600, 66647-350, 41657-300, 41627-100, 41677-600, 66626-450, 60646-450, 61647-200, 40637-700, 66637-600, 66627-800, 61626-350, 41647-600, 61657-200, 66647-300, 41647-550, 40627-700, 61647-350, 41657-500, 46627-600, 61637-700, 60677-200, 60647-700, 60657-700, 40637-400, 66637-300, 46637-200, 40646-250, 46657-200Model Breast expander

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04046745117173 Basic UDI-DI Date27 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Breast expander
Model / Reference
Breast expander, 61637-200, 46627-200, 66657-400, 46626-450, 46637-500, 61627-800, 40647-500, 66637-400, 66677-200, 60627-800, 46627-500, 61646-450, 66636-550, 41627-400, 46647-500, 66647-600, 40647-200, 61637-600, 61627-100, 61637-400, 66637-500, 61647-300, 40637-600, 66647-350, 41657-300, 41627-100, 41677-600, 66626-450, 60646-450, 61647-200, 40637-700, 66637-600, 66627-800, 61626-350, 41647-600, 61657-200, 66647-300, 41647-550, 40627-700, 61647-350, 41657-500, 46627-600, 61637-700, 60677-200, 60647-700, 60657-700, 40637-400, 66637-300, 46637-200, 40646-250, 46657-200
Primary DI / UDI-DI
04046745117173, 04046745113038, 04046745118545, 04046745113021, 04046745113243, 04046745117043, 04046745026062, 04046745118316, 04046745118583, 04046745116350, 04046745113069, 04046745117319, 04046745118286, 04046745026260, 04046745113403, 04046745118507, 04046745026048, 04046745117210, 04046745116978, 04046745117197, 04046745118323, 04046745117340, 04046745026024, 04046745118460, 04046745112628, 04046745026239, 04046745112710, 04046745118101, 04046745116619, 04046745117333, 04046745026031, 04046745118330, 04046745118170, 04046745116954, 04046745030762, 04046745117395, 04046745118453, 04046745119320, 04046745025966, 04046745120746, 04046745112642, 04046745113076, 04046745117227, 04046745116749, 04046745116671, 04046745116732, 04046745026000, 04046745118309, 04046745113212, 04046745112239, 04046745113441
Basic UDI-DI
B-04046745117173, B-04046745113038, B-04046745118545, B-04046745113021, B-04046745113243, B-04046745117043, B-04046745026062, B-04046745118316, B-04046745118583, B-04046745116350, B-04046745113069, B-04046745117319, B-04046745118286, B-04046745026260, B-04046745113403, B-04046745118507, B-04046745026048, B-04046745117210, B-04046745116978, B-04046745117197, B-04046745118323, B-04046745117340, B-04046745026024, B-04046745118460, B-04046745112628, B-04046745026239, B-04046745112710, B-04046745118101, B-04046745116619, B-04046745117333, B-04046745026031, B-04046745118330, B-04046745118170, B-04046745116954, B-04046745030762, B-04046745117395, B-04046745118453, B-04046745119320, B-04046745025966, B-04046745120746, B-04046745112642, B-04046745113076, B-04046745117227, B-04046745116749, B-04046745116671, B-04046745116732, B-04046745026000, B-04046745118309, B-04046745113212, B-04046745112239, B-04046745113441
EMDN Code
P060299 Breast implants, expander - other
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000018836

Other devices from POLYTECH Health & Aesthetics GmbH

See all devices from POLYTECH Health & Aesthetics GmbH →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No