- Role
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IL-MF-000015028D1302000007D1302000014B-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBI is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by G&G Biotechnology Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 22, 2026
B-07290109034607Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07290109034607
2 warnings recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Aug 20, 2018 | Dec 31, 2027 |
| Austria | Aug 20, 2018 | Dec 31, 2027 |
| Belgium | Aug 20, 2018 | Dec 31, 2027 |
| Bulgaria | Aug 20, 2018 | Dec 31, 2027 |
| Cyprus | Aug 20, 2018 | Dec 31, 2027 |
| Czechia | Aug 20, 2018 | Dec 31, 2027 |
| Denmark | Aug 20, 2018 | Dec 31, 2027 |
| Estonia | Aug 20, 2018 | Dec 31, 2027 |
| EL | Aug 20, 2018 | Dec 31, 2027 |
| Spain | Aug 20, 2018 | Dec 31, 2027 |
| Finland | Aug 20, 2018 | Dec 31, 2027 |
| France | Aug 20, 2018 | Dec 31, 2027 |
| Croatia | Aug 20, 2018 | Dec 31, 2027 |
| Hungary | Aug 20, 2018 | Dec 31, 2027 |
| Ireland | Aug 20, 2018 | Dec 31, 2027 |
| Iceland | Aug 20, 2018 | Dec 31, 2027 |
| Italy | Aug 20, 2018 | Dec 31, 2027 |
| Liechtenstein | Aug 20, 2018 | Dec 31, 2027 |
| Lithuania | Aug 20, 2018 | Dec 31, 2027 |
| Luxembourg | Aug 20, 2018 | Dec 31, 2027 |
| Latvia | Aug 20, 2018 | Dec 31, 2027 |
| Malta | Aug 20, 2018 | Dec 31, 2027 |
| Netherlands | Aug 20, 2018 | Dec 31, 2027 |
| Norway | Aug 20, 2018 | Dec 31, 2027 |
| Poland | Aug 20, 2018 | Dec 31, 2027 |
| Portugal | Aug 20, 2018 | Dec 31, 2027 |
| Romania | Aug 20, 2018 | Dec 31, 2027 |
| Sweden | Aug 20, 2018 | Dec 31, 2027 |
| Slovenia | Aug 20, 2018 | Dec 31, 2027 |
| Slovakia | Aug 20, 2018 | Dec 31, 2027 |
| Türkiye | Aug 20, 2018 | Dec 31, 2027 |
| XI | Aug 20, 2018 | Dec 31, 2027 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07290109034607Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-0729010903460715636-405LW25UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
P0601020202BREAST IMPLANTS, ANATOMICAL, MADE OF SILICONE, WITH TEXTURED SURFACENo 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.B-07290109033846On the marketB-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBIB-07290109035185On the marketB-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBIB-07290109032825On the marketB-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBIB-07290109034720On the marketB-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBIB-07290109030968On the marketB-Lite LWBI; Modular System (Gen I); B-Lite ;B-Lite/SL; B-Lite LWBIB-07290109030937On the marketNo certificate specifically references this device's Basic UDI-DI.