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Auto Hematology-Immunoassary GlycoHemoglobin Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref XQ-0059-06Model DH-88[H]Ref XQ-0059-07Model DH-88CS[H]
Identity
- Trade Name
- Auto Hematology-Immunoassary GlycoHemoglobin Analyzer EUDAMED
- Device Name
- Auto Hematology-Immunoassary GlycoHemoglobin Analyzer EUDAMED
- Model / Reference
- DH-88[H] EUDAMEDXQ-0059-06 EUDAMEDDH-88CS[H] EUDAMEDXQ-0059-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377304718 EUDAMED06941377304725 EUDAMED
- Basic UDI-DI
- B-06941377304718 EUDAMEDB-06941377304725 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Auto Hematology-Immunoassary GlycoHemoglobin Analyzer by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06941377304718 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED ab9505d8-7536-441b-9a08-d1e655605299 61 fields · synced Jul 20, 2026
- EUDAMED 2e57a3b6-0b1d-4ae2-95e4-59a095282267 61 fields · synced May 17, 2026