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Glycosylated Hemoglobin Reagent (Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref PO-0007-01Model PF08 25 tests/kitRef PO-0007-02Model PF08 50 tests/kit
Identity
- Trade Name
- Glycosylated Hemoglobin Reagent (Fluorescence Immunochromatography) EUDAMED
- Device Name
- Glycosylated Hemoglobin Reagent (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- PF08 25 tests/kit EUDAMEDPO-0007-01 EUDAMEDPF08 50 tests/kit EUDAMEDPO-0007-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377300406 EUDAMED06941377302523 EUDAMED
- Basic UDI-DI
- B-06941377300406 EUDAMEDB-06941377302523 EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) 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
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Glycosylated Hemoglobin Reagent (Fluorescence Immunochromatography) 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-06941377300406 | 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 6f8b50aa-20c2-4fc5-a448-976f9397683e 61 fields · synced Jul 14, 2026
- EUDAMED 4a9f294a-34cd-4dfe-b9be-f900ed616033 61 fields · synced Jul 14, 2026