Identity
- Trade Name
- SKIN ZONE EUDAMED
- Device Name
- SKIN ZONE EUDAMED
- Model / Reference
- Unique EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290119090587 EUDAMED
- Basic UDI-DI
- 729011909058729 EUDAMED
- Direct Marketing DI
- 07290119090587 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Skin Zone by Kivema 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 | 729011909058729 | Class I | Active |
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Manufacturer
- Manufacturer
- Kivema Ltd
- EUDAMED SRN
- IL-MF-000044588
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED c488d9e2-c957-4bb3-b236-99f57eec8002 61 fields · synced Jul 27, 2026