Identity
- Trade Name
- MECO EUDAMED
- Device Name
- Silicone foam dressing EUDAMED
- Model / Reference
- S74033 EUDAMEDMC023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926365545304 EUDAMED
- Basic UDI-DI
- 69263655200137X EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
The MECO silicone foam dressing is a non-invasive, wearable medical device designed for the assessment and management of wound care in various clinical settings. This Class IIb medical device offers accurate and reliable measurements through its proprietary micro-needle action technology, making it an ideal solution for both primary and secondary diagnostics.
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 | 69263655200137X | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Longterm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001161
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9ef07671-1847-4d18-ac30-e927d38f6a21 61 fields · synced Jun 22, 2026