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Glucose-6-Phosphate Dehydrogenase Deficiency GenoArray Diagnostic Kit
EUDAMEDClass IVD General (EU MDR)
Ref HBGA-G6PDModel 6 Tests/Kit
Identity
- Device Name
- Glucose-6-Phosphate Dehydrogenase Deficiency GenoArray Diagnostic Kit EUDAMED
- Model / Reference
- 6 Tests/Kit EUDAMEDHBGA-G6PD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942221701165 EUDAMED
- Basic UDI-DI
- B-06942221701165 EUDAMED
- EMDN Code
- W0106010199 MONOGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Glucose-6-Phosphate Dehydrogenase Deficiency GenoArray Diagnostic Kit by Chaozhou Hybribio Biochemistry 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-06942221701165 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chaozhou Hybribio Biochemistry Ltd.
- EUDAMED SRN
- CN-MF-000023818
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED b3bebab6-1fe8-4bc4-b028-06978a55ec6f 61 fields · synced Oct 8, 2026