Identity
- Device Name
- Wisdome Wearables EUDAMED
- Model / Reference
- Wsar001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 111882503780 EUDAMED
- Basic UDI-DI
- PP11188250378009 EUDAMED
- Direct Marketing DI
- 111882503780 EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Wisdome Wearables by Wisdome Wearables Ltd. — 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 | PP11188250378009 | Class I | Active |
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Manufacturer
- Manufacturer
- Wisdome Wearables Ltd.
- EUDAMED SRN
- IL-MF-000035967
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 185a7ead-a5a2-4bb0-aabe-72335e856974 61 fields · synced Jul 10, 2026