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B-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBI

by G&G Biotechnology Ltd. 1,000+ variants

Ref 20636-405LW25Model RPL® THP

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07290109032115 Basic UDI-DI 07290109032115UDI-DIDate16 Jul 2026RegisteredStatusActive

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

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 20 Aug 2018
  • Belgium since 20 Aug 2018
  • Bulgaria since 20 Aug 2018
  • Croatia since 20 Aug 2018
  • Cyprus since 20 Aug 2018
  • Czechia since 20 Aug 2018
  • Denmark since 20 Aug 2018
  • Estonia since 20 Aug 2018
  • Finland since 20 Aug 2018
  • France since 20 Aug 2018
  • Germany since 20 Aug 2018
  • Greece since 20 Aug 2018
  • Hungary since 20 Aug 2018
  • Iceland since 20 Aug 2018
  • Ireland since 20 Aug 2018
  • Italy since 20 Aug 2018
  • Latvia since 20 Aug 2018
  • Liechtenstein since 20 Aug 2018
  • Lithuania since 20 Aug 2018
  • Luxembourg since 20 Aug 2018
  • Malta since 20 Aug 2018
  • Netherlands since 20 Aug 2018
  • Northern Ireland since 20 Aug 2018
  • Norway since 20 Aug 2018
  • Poland since 20 Aug 2018
  • Portugal since 20 Aug 2018
  • Romania since 20 Aug 2018
  • Slovakia since 20 Aug 2018
  • Slovenia since 20 Aug 2018
  • Spain since 20 Aug 2018
  • Sweden since 20 Aug 2018
  • Türkiye since 20 Aug 2018

Last checked 30 Oct 2026.

Specification

EUDAMED

Device Name
B-Lite LWBI
Model / Reference
RPL® THP, 20636-405LW25
Primary DI / UDI-DI
07290109032115
Basic UDI-DI
B-07290109032115
EMDN Code
P0601020202 Breast implants, anatomical, made of silicone, with textured surface
Models / Variants
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000015028
Authorised representative
MedNet EC-REP III GmbH DE-AR-000011191

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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