Identity
- Device Name
- WISKY EUDAMED
- Model / Reference
- WISKY EUDAMED210330V100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 88001957000110 EUDAMED
- Basic UDI-DI
- B-88001957000110 EUDAMED
- EMDN Code
- Z119092 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wisky by Ark Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-88001957000110 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ark Inc.
- EUDAMED SRN
- KR-MF-000016123
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED ab39b37c-ce90-4978-8665-aa34f098269f 61 fields · synced Oct 6, 2026