COMSrefix
Ref 01.0004
COMSrefix (01.0004) is a medical device (EU MDR Class I; EMDN category wound treatment equipment) made by Piomic Medical AG, registered in EUDAMED on 28 Feb 2022 (Basic UDI-DI 764029615003DW), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764029615003DW 07640296150077 | Date28 Feb 2022 | StatusActive |
Official records
- EUDAMED public site 764029615003DW
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- single-patient-use strap
- Model / reference
- 01.0004
- Primary DI / UDI-DI
- 07640296150077
- Basic UDI-DI
- 764029615003DW
- EMDN code
- Z12019003 Wound treatment equipment
- Device class
- Class I
- 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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