Identity
- Trade Name
- evercare® XP Standard OP-gown, size M EUDAMED
- Device Name
- OP Gowns, sterile EUDAMED
- Model / Reference
- 2505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129112146 EUDAMED
- Basic UDI-DI
- 6438129B0034HB EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
evercare® XP Standard OP-gown, size M by OneMed Group Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438129B0034HB | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED 0c372b09-0690-4b63-9ecd-48b376dc3747 61 fields · synced Jun 18, 2026