Johnson & Johnson International
BE-MF-000008018 · Belgium · Diegem
Johnson & Johnson International is registered in the European database on medical devices as a manufacturer, with 83 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 82 |
|---|---|
| Class IIa | 1 |
Most frequent device types declared: EDP46, EDP614, EH6622H, EH6623H, EH6625E.
Among these devices, 82 are declared sterile, 82 implantable, 1 reusable.
Devices declared under this manufacturer
- ETHISORB
- LAPRA-TY II
- MERSILENE
- NUROLON
- PERMA-HAND
- VICRYL
Showing 12 of 83 declared devices.
Catalogue references include EH6623H, EH6734H, EH6768H, EH6802H, EH6857H, F4202.
European nomenclature codes declared: H010201020203, H010202020302, H010201020101, M9099, H900304, H900303.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 83 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 61 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | JOHNSON & JOHNSON INTERNATIONAL |
What it holds in Canada
| Licences on record | 12 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 8 |
| Class 4 devices | 4 |
| First licensed | 2003-05-26 |
Licence types: Device Family (8), Single Device (4).
Licensed under: ETHILON NYLON SUTURE, ETHIBOND POLYESTER SUTURES, PDS II (POLYDIOXANONE) SUTURE, PERMA HAND SILK SUTURE, PROLENE POLYPROPYLENE SUTURE, PROCEED SURGICAL MESH.
North American profile: Canada only. Johnson & Johnson International holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 730051 | supplemented | 2028-05-29 |
MDR 730030 | supplemented | 2027-12-19 |