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evercare ® Optimia Absorbent dressing, 15 x 20 cm
EUDAMEDClass I (EU MDR)
Ref 4534-01
Identity
- Trade Name
- evercare ® Optimia Absorbent dressing, 15 x 20 cm EUDAMED
- Device Name
- Absorbent Dressings with cellulose pad, non-sterile EUDAMED
- Model / Reference
- 4534-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129321173 EUDAMED
- Basic UDI-DI
- 6438129B0013H3 EUDAMED
- EMDN Code
- M040201 ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
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 ® Optimia Absorbent dressing, 15 x 20 cm 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 | 6438129B0013H3 | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED dd5f0730-ec9e-48a8-af95-c8d319dcfd5f 61 fields · synced Jul 10, 2026