OneMed Group Oy
FI-MF-000000642 · Finland · Helsinki
OneMed Group Oy is registered in the European database on medical devices as a manufacturer, with 1 004 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 1 004 |
|---|
Most frequent device types declared: 2000020.
Among these devices, 491 are declared sterile, 1 active.
Devices declared under this manufacturer
- Apotek Hjärtat ICA Engångshandskar av nitril, vit, storlek L (50 st)
- Embra® Optimia Nonwoven swabs 10 x 20 cm
- SELEFA® Nitrile Medical Exam gloves, Blue, AQUA, size M
- SELEFA® Vaginal tampon, X-ray detectable, diam. 55 mm
- evercare inLine® GRAVITY SET, NON-VENTED, PVC Free, 220 cm
- evercare inLine® GRAVITY SET, VENTED, BACKCHECK VALVE, 3-WAY STOPCOCK
- evercare inLine® GRAVITY SET, VENTED, FILTERSTOP, PVC Free, 320 cm
- evercare inLine® GRAVITY SET, VENTED, PVC Free, 180 cm
- evercare® XP warm-up jacket, short sleeve L
- evercare® Adhesive drape sheet 75 x 90 cm
- evercare® Essentia Standard OP-gown with hand towels, size XXL
- evercare® Hip set Standard
Showing 12 of 1 004 declared devices.
Catalogue references include 100009, 10509-01, 10581-01, 10591, 1210-02, 1460-02.
European nomenclature codes declared: T01020204, T020199, A03010101, T0299, T010201, T0207.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 004 |
| Country of registration | Finland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 1 003 |
|---|---|
| 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. OneMed Group Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000510541-PA-NoMA-DNK | issued | 2027-07-06 |
10000510540-PA-NoMA-DNK | issued | 2027-05-18 |