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Hematology Analyzer Dye
EUDAMEDClass A (EU MDR)
Ref 12.01.1986AModel D-80FD:12mLRef 12.01.1922ARef 12.01.1327AModel FDN-R:24mLRef 12.01.1996ARef 12.01.1425ARef XQ-0061-01Model D-80FR(M)Ref 12.01.1326ARef 12.01.1989ARef 12.01.1999A
Identity
- Trade Name
- Hematology Analyzer Dye EUDAMED
- Device Name
- Hematology Analyzer Dye EUDAMED
- Model / Reference
- D-80FD:12mL EUDAMED12.01.1986A EUDAMED12.01.1922A EUDAMEDFDN-R:24mL EUDAMED12.01.1327A EUDAMED12.01.1996A EUDAMED12.01.1425A EUDAMEDD-80FR(M) EUDAMEDXQ-0061-01 EUDAMED12.01.1326A EUDAMED12.01.1989A EUDAMED12.01.1999A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117452411 EUDAMED06976117452145 EUDAMED06970493099130 EUDAMED06976117452466 EUDAMED06970493099079 EUDAMED06941377302790 EUDAMED06970493091868 EUDAMED06941377300581 EUDAMED06976117452480 EUDAMED
- Basic UDI-DI
- 697049309W010300000039U EUDAMED697049309W010300000059Y EUDAMED697049309W01030000024A4 EUDAMED
- Direct Marketing DI
- 06976117452411 EUDAMED06976117452145 EUDAMED06970493099130 EUDAMED06976117452466 EUDAMED06970493099079 EUDAMED06941377302790 EUDAMED06970493091868 EUDAMED06941377300581 EUDAMED06976117452480 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematology Analyzer Dye by Shenzhen Dymind Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697049309W010300000039U | Class A | 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 (9)
- EUDAMED 489ffb82-adf7-4bd9-8d97-b36ed49b9942 61 fields · synced Oct 6, 2026
- EUDAMED 642ddc9b-b18b-4608-b87d-277888323ffb 61 fields · synced Jun 20, 2026
- EUDAMED c091af4d-b1de-4ba4-a425-5c14a5614403 61 fields · synced Jul 9, 2026
- EUDAMED c41abea2-4872-4a77-9862-24e78655cec6 61 fields · synced Jul 9, 2026
- EUDAMED d99da24a-4e30-4cd5-a952-7c41e7829ecb 61 fields · synced Jul 14, 2026
- EUDAMED f38dbb2d-7294-4ba6-ae33-28e03455bb91 61 fields · synced Jul 15, 2026
- EUDAMED ef2f58d4-33c6-4d21-828c-a21dda78efcd 61 fields · synced Jul 15, 2026
- EUDAMED 6fe47e41-d942-469f-a75b-34fafa686e0f 61 fields · synced Jul 20, 2026
- EUDAMED 4a49782b-b121-4011-9801-cf6441bfb895 61 fields · synced Jul 22, 2026