Identity
- Trade Name
- Skin Barrier Wipes EUDAMED
- Device Name
- SKIN BARRIER SPRAY EUDAMED
- Model / Reference
- 6024 EUDAMED120215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975700084046 EUDAMED
- Basic UDI-DI
- 697570008SkinBarrierN2 EUDAMED
- EMDN Code
- A108004 PROTECTIVE FILMS / SPRAYS FOR PERISTOMAL SKIN EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovenia 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 Barrier Wipes by Concarey Medical Technology Co., 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 | 697570008SkinBarrierN2 | Class I | Active |
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Manufacturer
- Manufacturer
- Concarey Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000035609
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 1c8e7347-46f7-4385-b0ed-a8e65bbc8f87 61 fields · synced Sep 18, 2026