COMS One basic
by Piomic Medical AG 2 variants
Ref 01.0008
COMS One basic (01.0008) is a medical device (EU MDR Class IIa; EMDN category wound treatment equipment) made by Piomic Medical AG, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 764029615000DQ), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764029615000DQ 07640296150060 | Date23 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 764029615000DQ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 01.0008
- Primary DI / UDI-DI
- 07640296150060
- Basic UDI-DI
- 764029615000DQ
- Direct marketing DI
- 07640296150022
- EMDN code
- Z12019003 Wound treatment equipment
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CH-MF-000013391
- Authorised representative
- EUMEDIQ GmbH DE-AR-000007809
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