Identity
- Trade Name
- COMStouch EUDAMED
- Device Name
- consumable EUDAMED
- Model / Reference
- 01.0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640296150008 EUDAMED
- Basic UDI-DI
- 764029615001DS EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
COMStouch by Piomic Medical AG — 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 | 764029615001DS | Class I | Active |
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Manufacturer
- Manufacturer
- Piomic Medical AG
- EUDAMED SRN
- CH-MF-000013391
- Authorised Representative
- EUMEDIQ GmbH DE-AR-000007809
Sources (1)
- EUDAMED ebe81202-45d7-4328-86a5-ce1a527a2d94 61 fields · synced Jul 10, 2026