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Hematology Analyzer Diluent
EUDAMEDClass A (EU MDR)
Ref 12.01.1950AModel D-80DIL:10LRef XQ-0011-02Model DIL-N:10LRef XQ-0037-02Model DIL-R:20LRef XQ-0033-03Model DIL-K:20LRef XQ-0019-02Model DIL-E:20LRef 12.01.1379ARef 12.01.1314ARef XQ-0060-02Model D-80DR(M)Ref XQ-0060-04Ref 12.01.1381ARef 12.01.1313ARef XQ-0060-03Ref 12.01.1907ARef 12.01.1317AModel DIL-R 10LRef XQ-0060-01Ref 12.01.1975A
Identity
- Trade Name
- Hematology Analyzer Diluent EUDAMED
- Device Name
- Hematology Analyzer Diluent EUDAMED
- Model / Reference
- D-80DIL:10L EUDAMED12.01.1950A EUDAMEDDIL-N:10L EUDAMEDXQ-0011-02 EUDAMEDDIL-R:20L EUDAMEDXQ-0037-02 EUDAMEDDIL-K:20L EUDAMEDXQ-0033-03 EUDAMEDDIL-E:20L EUDAMEDXQ-0019-02 EUDAMED12.01.1379A EUDAMED12.01.1314A EUDAMEDD-80DR(M) EUDAMEDXQ-0060-02 EUDAMEDXQ-0060-04 EUDAMED12.01.1381A EUDAMED12.01.1313A EUDAMEDXQ-0060-03 EUDAMED12.01.1907A EUDAMEDDIL-R 10L EUDAMED12.01.1317A EUDAMEDXQ-0060-01 EUDAMED12.01.1975A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117452275 EUDAMED06976117450028 EUDAMED06970493099970 EUDAMED06970493090366 EUDAMED06970493090540 EUDAMED06941377301304 EUDAMED06970493091837 EUDAMED06941377302769 EUDAMED06941377302745 EUDAMED06970493099109 EUDAMED06970493091844 EUDAMED06941377302752 EUDAMED06976117452015 EUDAMED06941377302776 EUDAMED06976117452381 EUDAMED
- Basic UDI-DI
- 697049309W010300000019Q EUDAMED697049309W010300000049W EUDAMED697049309W01030000019AB EUDAMED697049309W01030000017A7 EUDAMED697049309W01030000008A6 EUDAMED697049309W01030000027AA EUDAMED
- Direct Marketing DI
- 06976117452275 EUDAMED06976117450028 EUDAMED06970493099970 EUDAMED06970493090366 EUDAMED06970493090540 EUDAMED06941377301304 EUDAMED06970493091837 EUDAMED06941377302769 EUDAMED06941377302745 EUDAMED06970493099109 EUDAMED06970493091844 EUDAMED06941377302752 EUDAMED06976117452015 EUDAMED06941377302776 EUDAMED06976117452381 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
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematology Analyzer Diluent 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 | 697049309W010300000019Q | 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 (16)
- EUDAMED e1df3587-2be1-4af3-b48d-fa27d38f2747 61 fields · synced Oct 6, 2026
- EUDAMED 1fd7081b-bde0-4aea-9df1-31163b91fbe8 61 fields · synced May 16, 2026
- EUDAMED 380bb1b0-ab31-498b-b599-1181459c3a82 61 fields · synced May 18, 2026
- EUDAMED 102871af-baca-4eed-9413-a1aefab48405 61 fields · synced May 18, 2026
- EUDAMED 85a70e53-b4a2-4a63-a513-57636b239bb5 61 fields · synced May 18, 2026
- EUDAMED bbbb8b48-e127-4757-b05d-34c2787ec66b 61 fields · synced Jul 9, 2026
- EUDAMED cfbe47b6-f036-49c8-a471-f7d3d4faaa7a 61 fields · synced Jul 9, 2026
- EUDAMED 6925de1c-8011-429d-bff8-66c3c59dc492 61 fields · synced Jul 11, 2026
- EUDAMED 3cff4b55-457f-45f9-ab63-05b68435c97d 61 fields · synced Jul 14, 2026
- EUDAMED d0603814-1f53-4c43-9ed3-a09f7ed87b5b 61 fields · synced Jul 15, 2026
- EUDAMED 897c4833-bef2-46c2-8eea-0cfcbeddc4c0 61 fields · synced Jul 16, 2026
- EUDAMED 392b8774-3dab-4941-b414-013eca3f7223 61 fields · synced Jul 17, 2026
- EUDAMED d27ed18a-e489-4bea-b30b-e5ab83710317 61 fields · synced Jul 18, 2026
- EUDAMED 6b15c223-37ad-4637-9b43-7ff230f43d20 61 fields · synced Jul 18, 2026
- EUDAMED 328fe31d-fe09-4736-8762-21a166f73342 61 fields · synced Jul 22, 2026
- EUDAMED cf33c4d9-bf3f-447b-bd05-fdecc082df81 61 fields · synced Jul 29, 2026