Identity
- Trade Name
- Hydrocolloid dressing patch EUDAMED
- Device Name
- Hydrocolloid dressing patch EUDAMED
- Model / Reference
- AK-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978589538914 EUDAMED
- Basic UDI-DI
- 69785895306978589538914QW EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Hydrocolloid dressing patch by Ningbo Alps 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 | 69785895306978589538914QW | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Alps Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047878
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 4a121ef6-b547-4702-9932-89a6a5363c93 61 fields · synced Aug 4, 2026