HemoTek 2
by Delcon Srl
Part of a family of 19 devices: see the family page
Ref HTEK2.DB.00
HemoTek 2 (HTEK2.DB.00) is a Class I device made by Delcon SRL, registered in EUDAMED on 27 Dec 2021 (Basic UDI-DI 803392853MIXEGQ), active as of 24 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 | Number803392853MIXEGQ 08033928530573 | Date27 Dec 2021 | StatusActive |
Official records
- EUDAMED public site 803392853MIXEGQ
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- Withdrawn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
- Mixer
- Model / reference
- HTEK2.DB.00
- Primary DI / UDI-DI
- 08033928530573
- Basic UDI-DI
- 803392853MIXEGQ
- Direct marketing DI
- 08033928530573
- EMDN code
- B0180 Blood bags and kits - accessories
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000014234
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