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Hematology Control

EUDAMED

Class IVD General (EU MDR)

Ref XQ-0005-01Model DM-3D:3ml(H)*1Ref XQ-0007-01Model DM-5D,High:3mL×1Ref XQ-0070-01Model DM-RET：1*3ml(H)Ref XQ-0069-01Model DM-6D：1*3ml(H)Ref XQ-0070-02Model DM-RET 3 mL×2 (H)Ref XQ-0070-05Model DM-RET 3 mL×2 (N)Ref XQ-0005-04Model DM-3D Normal (N):3mL×1Ref XQ-0071-07Model DM-BF 3 mL×1 (L)Ref XQ-0005-07Model DM-3D Low (L):3mL×1Ref XQ-0091-02Model Model:DM-6DR , Specification:3mL（H）×2Ref XQ-0069-05Model Model:DM-6D Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL (N)×1、3 mL(N)×2 、3 mL(N)×3 、3 mL (L)×1、3 mL(L)×2 、3 mL (L)×3、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1Model DM-3D High (H):3mL×1Ref XQ-0093-05Model Model:DM-6DR,Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×1Ref XQ-0091-01Model Model:DM-6DR , Specification:3mL（H）×1Ref XQ-0007-09Model DM-5D Low (L):3mL×3Ref XQ-0100-07Model DH-RET 3 mL×1 (L)Ref XQ-0069-09Model DM-6D 3 mL×3 (L)Ref XQ-0069-07Model DM-6D 3 mL×1 (L)Ref XQ-0005-02Model 型号：DM-3D 规格：High (H):3mL×2Ref XQ-0005-03Model 型号：DM-3D 规格：High (H):3mL×3Ref XQ-0100-04Model DH-RET 3 mL×1 (N)Ref XQ-0069-02Model DM-6D 3 mL×2 (H)Ref XQ-0007-04Model DM-5D Normal (N):3mL×1Ref XQ-0007-10Model DM-5D Control set:3mL (H) ×1, 3mL (N) ×1, 3mL (L) ×1Ref XQ-0071-04Model DM-BF 3 mL×1 (N)Ref XQ-0005-09Model DM-3D Low (L):3mL×3Ref XQ-0070-07Model DM-RET 3 mL×1 (L)Ref XQ-0070-08Model DM-RET 3 mL×2 (L)Ref XQ-0070-03Model DM-RET 3 mL×3 (H)Ref XQ-0069-10Model DM-6D 3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1Ref XQ-0070-10Model DM-RET 3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1Ref XQ-0071-06Model DM-BF 3 mL×3 (N)Ref XQ-0007-03Model DM-5D High (H):3mL×3Ref XQ-0070-09Model DM-RET 3 mL×3 (L)Ref XQ-0070-04Model DM-RET 3 mL×1 (N)Model DM-6D 3 mL×2 (N)Model Model:DM-RET Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL×(N)1 、3 mL(N)×2 、3 mL (N)×3、3 mL(L)×1 、3 mL(L)×2 、3 mL(L)×3 、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
Hematology Control EUDAMED
Device Name
Hematology Control EUDAMED
Model / Reference
DM-3D:3ml(H)*1 EUDAMED
XQ-0005-01 EUDAMED
DM-5D,High:3mL×1 EUDAMED
XQ-0007-01 EUDAMED
DM-RET：1*3ml(H) EUDAMED
XQ-0070-01 EUDAMED
DM-6D：1*3ml(H) EUDAMED
XQ-0069-01 EUDAMED
DM-RET 3 mL×2 (H) EUDAMED
XQ-0070-02 EUDAMED
DM-RET 3 mL×2 (N) EUDAMED
XQ-0070-05 EUDAMED
DM-3D Normal (N):3mL×1 EUDAMED
XQ-0005-04 EUDAMED
DM-BF 3 mL×1 (L) EUDAMED
XQ-0071-07 EUDAMED
DM-3D Low (L):3mL×1 EUDAMED
XQ-0005-07 EUDAMED
Model:DM-6DR , Specification:3mL（H）×2 EUDAMED
XQ-0091-02 EUDAMED
Model:DM-6D Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL (N)×1、3 mL(N)×2 、3 mL(N)×3 、3 mL (L)×1、3 mL(L)×2 、3 mL (L)×3、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1 EUDAMED
XQ-0069-05 EUDAMED
DM-3D High (H):3mL×1 EUDAMED
Model:DM-6DR,Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×1 EUDAMED
XQ-0093-05 EUDAMED
Model:DM-6DR , Specification:3mL（H）×1 EUDAMED
XQ-0091-01 EUDAMED
DM-5D Low (L):3mL×3 EUDAMED
XQ-0007-09 EUDAMED
DH-RET 3 mL×1 (L) EUDAMED
XQ-0100-07 EUDAMED
DM-6D 3 mL×3 (L) EUDAMED
XQ-0069-09 EUDAMED
DM-6D 3 mL×1 (L) EUDAMED
XQ-0069-07 EUDAMED
型号：DM-3D 规格：High (H):3mL×2 EUDAMED
XQ-0005-02 EUDAMED
型号：DM-3D 规格：High (H):3mL×3 EUDAMED
XQ-0005-03 EUDAMED
DH-RET 3 mL×1 (N) EUDAMED
XQ-0100-04 EUDAMED
DM-6D 3 mL×2 (H) EUDAMED
XQ-0069-02 EUDAMED
DM-5D Normal (N):3mL×1 EUDAMED
XQ-0007-04 EUDAMED
DM-5D Control set:3mL (H) ×1, 3mL (N) ×1, 3mL (L) ×1 EUDAMED
XQ-0007-10 EUDAMED
DM-BF 3 mL×1 (N) EUDAMED
XQ-0071-04 EUDAMED
DM-3D Low (L):3mL×3 EUDAMED
XQ-0005-09 EUDAMED
DM-RET 3 mL×1 (L) EUDAMED
XQ-0070-07 EUDAMED
DM-RET 3 mL×2 (L) EUDAMED
XQ-0070-08 EUDAMED
DM-RET 3 mL×3 (H) EUDAMED
XQ-0070-03 EUDAMED
DM-6D 3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1 EUDAMED
XQ-0069-10 EUDAMED
DM-RET 3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1 EUDAMED
XQ-0070-10 EUDAMED
DM-BF 3 mL×3 (N) EUDAMED
XQ-0071-06 EUDAMED
DM-5D High (H):3mL×3 EUDAMED
XQ-0007-03 EUDAMED
DM-RET 3 mL×3 (L) EUDAMED
XQ-0070-09 EUDAMED
DM-RET 3 mL×1 (N) EUDAMED
XQ-0070-04 EUDAMED
DM-6D 3 mL×2 (N) EUDAMED
Model:DM-RET Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL×(N)1 、3 mL(N)×2 、3 mL (N)×3、3 mL(L)×1 、3 mL(L)×2 、3 mL(L)×3 、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1 EUDAMED

Identifiers

Primary DI / UDI-DI
06970493096429 EUDAMED
06970493096559 EUDAMED
06970493091899 EUDAMED
06970493092636 EUDAMED
06970493091905 EUDAMED
06970493091936 EUDAMED
06970493096450 EUDAMED
06976117451988 EUDAMED
06970493096481 EUDAMED
06941377307115 EUDAMED
06970493092674 EUDAMED
06941377307023 EUDAMED
06941377307108 EUDAMED
06970493096634 EUDAMED
06941377304589 EUDAMED
06970493092711 EUDAMED
06970493092698 EUDAMED
06970493096436 EUDAMED
06970493096443 EUDAMED
06941377304596 EUDAMED
06970493092643 EUDAMED
06970493096580 EUDAMED
06970493096641 EUDAMED
06976117451957 EUDAMED
06970493096504 EUDAMED
06970493091950 EUDAMED
06970493091967 EUDAMED
06970493091912 EUDAMED
06970493092728 EUDAMED
06970493091981 EUDAMED
06976117451971 EUDAMED
06970493096573 EUDAMED
06970493091974 EUDAMED
06970493091929 EUDAMED
Basic UDI-DI
B-06970493096429 EUDAMED
B-06970493096559 EUDAMED
B-06970493091899 EUDAMED
B-06970493092636 EUDAMED
B-06970493091905 EUDAMED
B-06970493091936 EUDAMED
B-06970493096450 EUDAMED
B-06976117451988 EUDAMED
B-06970493096481 EUDAMED
B-06941377307115 EUDAMED
697049309W01033012002C6 EUDAMED
6970493090608005PU EUDAMED
697049309W01033013001CB EUDAMED
B-06941377307108 EUDAMED
B-06970493096634 EUDAMED
B-06941377304589 EUDAMED
B-06970493092711 EUDAMED
B-06970493092698 EUDAMED
B-06970493096436 EUDAMED
B-06970493096443 EUDAMED
B-06941377304596 EUDAMED
B-06970493092643 EUDAMED
B-06970493096580 EUDAMED
B-06970493096641 EUDAMED
B-06976117451957 EUDAMED
B-06970493096504 EUDAMED
B-06970493091950 EUDAMED
B-06970493091967 EUDAMED
B-06970493091912 EUDAMED
B-06970493092728 EUDAMED
B-06970493091981 EUDAMED
B-06976117451971 EUDAMED
B-06970493096573 EUDAMED
B-06970493091974 EUDAMED
B-06970493091929 EUDAMED
B-06970493092674 EUDAMED
697049309W01033012003C8 EUDAMED
Direct Marketing DI
06970493092674 EUDAMED
06970493096450 EUDAMED
06941377307023 EUDAMED
06970493091905 EUDAMED
EMDN Code
W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
W0103010506 RETICULOCYTE CONTROLS EUDAMED
W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
W0103010501 NORMAL BLOOD CONTROLS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class B EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMEDEUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

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 Control by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen Dymind Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000024842
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (37)

  • EUDAMED f52c6619-7619-427f-9b58-a8dbef0de344 61 fields · synced Oct 6, 2026
  • EUDAMED 62369ec1-4087-4f17-a6eb-b40f4538137e 61 fields · synced May 18, 2026
  • EUDAMED 8a75b4e9-442b-46ab-b773-1f69ab00e53e 61 fields · synced May 18, 2026
  • EUDAMED 084f7d52-fda9-44f8-bc2d-068fbc435ab0 61 fields · synced May 18, 2026
  • EUDAMED a17411c5-e246-4fe7-9b72-71bf1707d2a3 61 fields · synced Jun 18, 2026
  • EUDAMED 7020f3b0-6f35-4e7e-9cdb-a3c7f8eb4568 61 fields · synced Jun 19, 2026
  • EUDAMED 5c4a118f-6b8b-492e-856a-7f19d71c20d5 61 fields · synced Jun 19, 2026
  • EUDAMED 9d3b7781-676d-4c0a-87df-58e0c06d5fcf 61 fields · synced Jun 20, 2026
  • EUDAMED eab212f5-b517-4149-912b-1ba88a831a7f 61 fields · synced Jun 20, 2026
  • EUDAMED 84c562b4-137f-4750-b01c-a29b17ffbe40 61 fields · synced Jul 8, 2026
  • EUDAMED 83453919-a876-47cf-b548-7b964f89142d 61 fields · synced Jul 8, 2026
  • EUDAMED df1df58c-28d3-4854-a579-a35119c820b9 61 fields · synced Jul 8, 2026
  • EUDAMED cb230b10-8a67-4162-aba4-ecb832daad33 61 fields · synced Jul 8, 2026
  • EUDAMED ab726434-d5ca-44b3-af8c-55c36aa08423 61 fields · synced Jul 8, 2026
  • EUDAMED 6b5bbb82-824f-41c8-bc34-abbdf90729a0 61 fields · synced Jul 9, 2026
  • EUDAMED ec19e479-c089-4790-8bc5-e331198ad7b0 61 fields · synced Jul 9, 2026
  • EUDAMED f1efbe17-ac9d-43cc-aaaf-3a60fb21a4fb 61 fields · synced Jul 9, 2026
  • EUDAMED 39f5a7b2-dd8a-46ee-b767-7c6e69a5cb20 61 fields · synced Jul 9, 2026
  • EUDAMED 9924ed05-81df-44e2-90e8-8e9c2ce325f5 61 fields · synced Jul 10, 2026
  • EUDAMED 9a62bbbd-2513-487a-804b-52b6530b77dc 61 fields · synced Jul 12, 2026
  • EUDAMED 1bd4de6c-323c-495e-9334-9ba73b8a0156 61 fields · synced Jul 12, 2026
  • EUDAMED 9289e61b-1a8c-4861-b167-a7edbbeea7d9 61 fields · synced Jul 13, 2026
  • EUDAMED 4ca73372-bb40-4fa9-b000-f14695abaa8c 61 fields · synced Jul 13, 2026
  • EUDAMED 113be9c6-7f46-4a94-bd11-d04fa949da2b 61 fields · synced Jul 14, 2026
  • EUDAMED 9ab615af-fb6d-48a7-8c7b-b20b66f71038 61 fields · synced Jul 14, 2026
  • EUDAMED 0abd8e9d-1158-416a-bd17-0a21e07c082a 61 fields · synced Jul 15, 2026
  • EUDAMED 8c699f09-4a4e-4e6a-9b25-f8340fe6666b 61 fields · synced Jul 15, 2026
  • EUDAMED 7b9a1c57-416e-4d11-98b2-b065b36d251f 61 fields · synced Jul 16, 2026
  • EUDAMED d83951fe-831c-4984-bbb0-9e3278f9f74a 61 fields · synced Jul 18, 2026
  • EUDAMED e377d0ea-de6c-4998-91bc-cde38365ab61 61 fields · synced Jul 20, 2026
  • EUDAMED 9c90ec2b-1833-4015-b1a5-26b977e2d2ec 61 fields · synced Jul 20, 2026
  • EUDAMED 8aea8c8d-d736-4d05-972a-20dd55302cd9 61 fields · synced Jul 23, 2026
  • EUDAMED 5a345ad7-21fc-4572-89ee-c6e56491117a 61 fields · synced Jul 24, 2026
  • EUDAMED c8595971-f01e-4e62-88b8-8055fa72ce4b 61 fields · synced Jul 24, 2026
  • EUDAMED ee75ed79-4dd5-4063-b14d-37bf71e9fb24 61 fields · synced Jul 27, 2026
  • EUDAMED 8fc58a0e-08c7-4fa6-b761-32fcf315ea8b 61 fields · synced Jul 28, 2026
  • EUDAMED 5440066b-0403-47e5-b3de-e4128bc82ef6 61 fields · synced Aug 1, 2026