Haiim Vacuum-assisted blood collection system Main Device (NPT)
Ref HD-002Model WH-002
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number471988964WH-002LS 04719889640189 | Date10 Aug 2026 | StatusActive |
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- Withdrawn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/IVDR Active
Specification
- Device Name
- "Haiim" Vacuum-assisted blood collection system (NPT)
- Model / Reference
- WH-002, HD-002
- Primary DI / UDI-DI
- 04719889640189
- Basic UDI-DI
- 471988964WH-002LS
- Direct Marketing DI
- 04719889640189
- EMDN Code
- W0501010201 Capillary blood collection systems
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- TW-MF-000036356
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Winnoz Technology, Inc.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Companion Diagnostics: No
- New Device: No