Hematology Analyzer Lyse
by Guangdong Hao Jiang Laboratories Co., Ltd. EUDAMED
Active
Ref HL1：400mLModel HL1：400mL、500mL、1L、20L，HL2：15mL、17mL、17mL×18，HL3：1L、5L，HL4：500mL、500mL×3、5L，HL5：500mL、1L， HL7：100mL、500mL、1L，HL8：1L，etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number698035178HALR2 | Date10 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Hematology Analyzer Lyse
- Model / Reference
- HL1：400mL、500mL、1L、20L，HL2：15mL、17mL、17mL×18，HL3：1L、5L，HL4：500mL、500mL×3、5L，HL5：500mL、1L， HL7：100mL、500mL、1L，HL8：1L，etc, HL1：400mL
- Primary DI / UDI-DI
- 06980351780414
- Basic UDI-DI
- 698035178HALR2
- EMDN Code
- W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000057458
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guangdong Hao Jiang Laboratories Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No