Identity
- Trade Name
- COMSfix EUDAMED
- Device Name
- Single-use Strap EUDAMED
- Model / Reference
- 01.0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640296150053 EUDAMED
- Basic UDI-DI
- 764029615002DU EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
COMSfix 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 | 764029615002DU | 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 580aacd4-d329-464f-932e-2c0b92ce7f6c 61 fields · synced Jun 18, 2026