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evercare® Optimia Clean air suit, shirt, size S
EUDAMEDClass I (EU MDR)
Ref 2661
Identity
- Trade Name
- evercare® Optimia Clean air suit, shirt, size S EUDAMED
- Device Name
- Clean Air Suits, non-sterile EUDAMED
- Model / Reference
- 2661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129518399 EUDAMED
- Basic UDI-DI
- 6438129B0041H8 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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 Clean air suit, shirt, size S 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 | 6438129B0041H8 | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED c3182e73-1add-4a09-8427-e1e228fb07a4 61 fields · synced Jul 30, 2026