Identity
- Trade Name
- COMS One basic EUDAMED
- Device Name
- COMS One basic EUDAMED
- Model / Reference
- 01.0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640296150022 EUDAMED
- Basic UDI-DI
- 764029615000DQ EUDAMED
- Direct Marketing DI
- 07640296150022 EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
COMS One basic by Piomic Medical AG — Class IIa — 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 | 764029615000DQ | Class IIa | 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 688ea637-c3e9-4593-a57b-5ade612ddc3a 61 fields · synced Jul 22, 2026