BABGENCEL GmbH
DE-MF-000019691 · Germany · Düsseldorf
BABGENCEL GmbH is registered in the European database on medical devices as a manufacturer, with 578 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 578 |
|---|
Most frequent device types declared: 20AS01 / 20AS01 / 20AS03, 20AW01 / 20AW02 / 20AW03, 20EZ01, 20HW01 / 20HW02, 20HX01 / 20HX02.
Devices declared under this manufacturer
- Alvatech Rolls XL
- Alvatech BIO
- Alvatech Wipes P
- BG Quick
- BG Quick BD Wipes
- BioClean IPA Wipes
- Enzycare 2 in 1 Wipes
- Hexadermal MD BIO Wipes
- Hexadermal MD Natural Rolls
- Hexadermal MD Natural Wipes
- Hexadermal MD Rolls
- Hexadermal MD Spray
Showing 12 of 578 declared devices.
Catalogue references include 20AW01-MS203T310, 20HW01-LE113R120, 20HW01-MS103T845, 20ZW01-AG104T404, 20ZW01-CL104T110, 20ZW01-CL104T404.
European nomenclature codes declared: D99, D0701, D0902, D0702, D0901.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 578 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 578 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. BABGENCEL GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR00145-A | issued | 2030-02-03 |