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Hematology Analyzer Lyse

EUDAMED

Class A (EU MDR)

Ref XQ-0016-03Model LYN-G:1LRef XQ-0025-06Model LYC-1：1LRef XQ-0018-03Model LYE-1：1LRef MY-0013-03Model L1：1LRef PO-0002-02Ref XQ-0022-03Model LYA-1：1LRef XQ-0034-03Model LYR-1:1LRef XQ-0031-04Model LYD-1：1LRef XQ-0036-03Ref XQ-0035-04Ref XQ-0015-02Ref XQ-0032-03Model LYK-1Ref 12.01.1936AModel D-80LD:1LRef XQ-0020-03Ref XQ-0067-02Model LPRef 12.02.0820ARef 12.01.1411ARef XQ-0067-04Ref 12.01.1408ARef 12.01.1965ARef 12.02.0642ARef 12.01.1358ARef 12.01.1349ARef 12.01.1422ARef 12.01.1949ARef 12.01.1397ARef 12.02.0647ARef 12.02.0817ARef 12.02.0638ARef 12.02.0639ARef 12.02.0646ARef 12.01.1331ARef 12.01.1415ARef 12.01.1404ARef 12.01.1419ARef 12.01.1361ARef 12.01.1312AModel LYG-1Ref 12.01.1348ARef 12.01.1414ARef 12.01.1423ARef 12.01.1342ARef 12.01.1967ARef 12.01.1417ARef 12.02.0821ARef 12.01.1914ARef 12.01.1357ARef XQ-0067-01Ref 12.01.1968ARef 12.01.1412ARef 12.01.1969ARef 12.01.1359A

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
Hematology Analyzer Lyse EUDAMED
Device Name
Hematology Analyzer Lyse EUDAMED
Model / Reference
LYN-G:1L EUDAMED
XQ-0016-03 EUDAMED
LYC-1：1L EUDAMED
XQ-0025-06 EUDAMED
LYE-1：1L EUDAMED
XQ-0018-03 EUDAMED
L1：1L EUDAMED
MY-0013-03 EUDAMED
PO-0002-02 EUDAMED
LYA-1：1L EUDAMED
XQ-0022-03 EUDAMED
LYR-1:1L EUDAMED
XQ-0034-03 EUDAMED
LYD-1：1L EUDAMED
XQ-0031-04 EUDAMED
XQ-0036-03 EUDAMED
XQ-0035-04 EUDAMED
XQ-0015-02 EUDAMED
LYK-1 EUDAMED
XQ-0032-03 EUDAMED
D-80LD:1L EUDAMED
12.01.1936A EUDAMED
XQ-0020-03 EUDAMED
LP EUDAMED
XQ-0067-02 EUDAMED
12.02.0820A EUDAMED
12.01.1411A EUDAMED
XQ-0067-04 EUDAMED
12.01.1408A EUDAMED
12.01.1965A EUDAMED
12.02.0642A EUDAMED
12.01.1358A EUDAMED
12.01.1349A EUDAMED
12.01.1422A EUDAMED
12.01.1949A EUDAMED
12.01.1397A EUDAMED
12.02.0647A EUDAMED
12.02.0817A EUDAMED
12.02.0638A EUDAMED
12.02.0639A EUDAMED
12.02.0646A EUDAMED
12.01.1331A EUDAMED
12.01.1415A EUDAMED
12.01.1404A EUDAMED
12.01.1419A EUDAMED
12.01.1361A EUDAMED
LYG-1 EUDAMED
12.01.1312A EUDAMED
12.01.1348A EUDAMED
12.01.1414A EUDAMED
12.01.1423A EUDAMED
12.01.1342A EUDAMED
12.01.1967A EUDAMED
12.01.1417A EUDAMED
12.02.0821A EUDAMED
12.01.1914A EUDAMED
12.01.1357A EUDAMED
XQ-0067-01 EUDAMED
12.01.1968A EUDAMED
12.01.1412A EUDAMED
12.01.1969A EUDAMED
12.01.1359A EUDAMED

Identifiers

Primary DI / UDI-DI
06976117450004 EUDAMED
06970493091356 EUDAMED
06970493099536 EUDAMED
06970493097037 EUDAMED
06970493092957 EUDAMED
06970493096771 EUDAMED
06970493099864 EUDAMED
06970493099635 EUDAMED
06970493099949 EUDAMED
06970493099918 EUDAMED
06970493091875 EUDAMED
06941377301328 EUDAMED
06976117452053 EUDAMED
06970493096696 EUDAMED
06941377302837 EUDAMED
06970493092964 EUDAMED
06970493091318 EUDAMED
06941377302851 EUDAMED
06970493099574 EUDAMED
06976117452350 EUDAMED
06970493096917 EUDAMED
06970493096689 EUDAMED
06970493099567 EUDAMED
06970493096757 EUDAMED
06976117452282 EUDAMED
06970493099956 EUDAMED
06976117459199 EUDAMED
06970493097044 EUDAMED
06970493096955 EUDAMED
06970493096948 EUDAMED
06970493097013 EUDAMED
06941377301311 EUDAMED
06970493091370 EUDAMED
06970493099604 EUDAMED
06970493096702 EUDAMED
06970493096726 EUDAMED
06970493090304 EUDAMED
06970493099550 EUDAMED
06970493091363 EUDAMED
06970493096788 EUDAMED
06970493099901 EUDAMED
06976117452374 EUDAMED
06970493091417 EUDAMED
06976117452060 EUDAMED
06970493092810 EUDAMED
06941377302820 EUDAMED
06976117452176 EUDAMED
06970493091349 EUDAMED
06976117452183 EUDAMED
06970493096672 EUDAMED
Basic UDI-DI
697049309W01030000006A2 EUDAMED
697049309W010300000119T EUDAMED
697049309W01030000007A4 EUDAMED
697049309W010300000149Z EUDAMED
697049309W01030000009A8 EUDAMED
697049309W01030000018A9 EUDAMED
697049309W01030000015A3 EUDAMED
697049309W01030000016A5 EUDAMED
697049309W010300000029S EUDAMED
697049309W01030000023A2 EUDAMED
697049309W010300000139X EUDAMED
Direct Marketing DI
06976117450004 EUDAMED
06970493091356 EUDAMED
06970493099536 EUDAMED
06970493097037 EUDAMED
06970493092957 EUDAMED
06970493096771 EUDAMED
06970493099864 EUDAMED
06970493099635 EUDAMED
06970493099949 EUDAMED
06970493099918 EUDAMED
06970493091875 EUDAMED
06941377301328 EUDAMED
06976117452053 EUDAMED
06970493096696 EUDAMED
06970493092964 EUDAMED
06970493091318 EUDAMED
06941377302851 EUDAMED
06970493099574 EUDAMED
06976117452350 EUDAMED
06970493096917 EUDAMED
06970493096689 EUDAMED
06970493099567 EUDAMED
06970493096757 EUDAMED
06976117452282 EUDAMED
06970493099956 EUDAMED
06976117459199 EUDAMED
06970493097044 EUDAMED
06970493096955 EUDAMED
06970493096948 EUDAMED
06970493097013 EUDAMED
06941377301311 EUDAMED
06970493091370 EUDAMED
06970493099604 EUDAMED
06970493096702 EUDAMED
06970493096726 EUDAMED
06970493090304 EUDAMED
06970493099550 EUDAMED
06970493091363 EUDAMED
06970493096788 EUDAMED
06970493099901 EUDAMED
06976117452374 EUDAMED
06970493091417 EUDAMED
06976117452060 EUDAMED
06970493092810 EUDAMED
06941377302820 EUDAMED
06976117452176 EUDAMED
06970493091349 EUDAMED
06976117452183 EUDAMED
06970493096672 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 Lyse 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (51)

  • EUDAMED 3d7e5fe3-7e70-4aa0-a2cf-760d6cbdc908 61 fields · synced Oct 6, 2026
  • EUDAMED fefc6187-be58-4141-a717-3f455fb0d953 61 fields · synced May 16, 2026
  • EUDAMED 85485239-a201-4e01-91bf-ab1980c151d4 61 fields · synced May 16, 2026
  • EUDAMED 6ec5029e-5aba-4511-9be6-2e23ec721d5b 61 fields · synced May 16, 2026
  • EUDAMED d692b6c1-aaa3-408e-8086-c1466d6defcb 61 fields · synced May 17, 2026
  • EUDAMED 4bb42f8f-da42-48b6-80e2-2ce6d308ffba 61 fields · synced May 17, 2026
  • EUDAMED 590dbb77-ea5b-4c3a-8f56-c5594688cf16 61 fields · synced May 17, 2026
  • EUDAMED c02174ee-5d9b-435a-a3fb-1005865bd0ab 61 fields · synced May 17, 2026
  • EUDAMED 3db792d7-05cc-4c3f-a865-b9c8722e0d54 61 fields · synced May 17, 2026
  • EUDAMED 8caf4bbb-deb6-4c84-aef9-6b530c2a6755 61 fields · synced May 17, 2026
  • EUDAMED f88c65b6-7847-4638-8695-6d910500fc7f 61 fields · synced May 17, 2026
  • EUDAMED 8a702ca9-f1be-4fc8-9c2c-f553bbfe72ca 61 fields · synced May 18, 2026
  • EUDAMED 6ee886f7-03f1-411c-ac38-425d36152b47 61 fields · synced May 18, 2026
  • EUDAMED 45748f26-ed18-4967-bc57-bc4478321a65 61 fields · synced May 18, 2026
  • EUDAMED 0773ba2f-7d5c-4c20-8a51-e4c6d84c7e7e 61 fields · synced May 19, 2026
  • EUDAMED a7f7f9c6-f944-40ff-9756-81da935825d9 61 fields · synced Jun 14, 2026
  • EUDAMED 295e5bc6-edfa-41bc-b72a-b458efc2616f 61 fields · synced Jun 20, 2026
  • EUDAMED 0bbc9ae9-52bd-441b-a643-ecf5509ecdd7 61 fields · synced Jun 20, 2026
  • EUDAMED e22ad7ca-fc64-4524-8f0a-8ff3fa58bee4 61 fields · synced Jul 9, 2026
  • EUDAMED b3d7a0c8-311e-4b91-a42e-1f896423711c 61 fields · synced Jul 9, 2026
  • EUDAMED 1460f988-d0a4-4f26-a3a6-8c5d909e2c17 61 fields · synced Jul 9, 2026
  • EUDAMED 567d85b2-bc8d-4297-b341-60099d761878 61 fields · synced Jul 9, 2026
  • EUDAMED 7ce9a3bc-7a0e-479d-816c-0f3fdb560d13 61 fields · synced Jul 9, 2026
  • EUDAMED 52ef4437-ef70-49af-a573-4d4dd61e1dc9 61 fields · synced Jul 9, 2026
  • EUDAMED d5a5614a-5a16-418a-9c77-bd887479181a 61 fields · synced Jul 9, 2026
  • EUDAMED 1d762959-5f74-419a-8e7d-b36eb35f3f16 61 fields · synced Jul 10, 2026
  • EUDAMED 258dd25f-c70c-489a-beba-4b1fcec5087b 61 fields · synced Jul 10, 2026
  • EUDAMED ca359bcc-7a49-456d-949e-3428e5e8b102 61 fields · synced Jul 11, 2026
  • EUDAMED c31f4373-e402-4424-ae1a-5ad1bec2971a 61 fields · synced Jul 12, 2026
  • EUDAMED 3a91aa10-ceef-4032-88bf-bff2fd918469 61 fields · synced Jul 13, 2026
  • EUDAMED 7eb9e8f1-cb4f-4f3f-a08c-a031e95a27f6 61 fields · synced Jul 13, 2026
  • EUDAMED 508134a5-a143-4dfa-86e2-4695b8eb9f79 61 fields · synced Jul 13, 2026
  • EUDAMED 2cc92a41-5520-42a2-a422-f8fdeac4ebd2 61 fields · synced Jul 13, 2026
  • EUDAMED d423073a-3fd2-4fdf-af82-c8ece485c729 61 fields · synced Jul 14, 2026
  • EUDAMED d2067416-c344-41f2-8c18-b7808e8573b6 61 fields · synced Jul 14, 2026
  • EUDAMED 4c3b33cb-f56b-4039-8fb6-4e8945ddaa3a 61 fields · synced Jul 15, 2026
  • EUDAMED df791a81-142f-4073-b7c9-0c6daf635a71 61 fields · synced Jul 15, 2026
  • EUDAMED 1f1a9e48-b549-43c0-b81e-1712e44209d4 61 fields · synced Jul 16, 2026
  • EUDAMED 276e7a3d-4c7d-49bc-b4ee-3960ea822899 61 fields · synced Jul 17, 2026
  • EUDAMED 1d3bd730-dceb-4eb7-a78b-f2c69e5b77ae 61 fields · synced Jul 18, 2026
  • EUDAMED 0c1148a5-cd75-450b-b5d8-36581618d9b7 61 fields · synced Jul 19, 2026
  • EUDAMED e8a844af-ddac-489d-bab6-4b90873f89ec 61 fields · synced Jul 20, 2026
  • EUDAMED 451ef9ac-2cef-48c5-94d9-77088cdf08f6 61 fields · synced Jul 21, 2026
  • EUDAMED 9585ef2e-fc1c-4a1a-96e7-203b9c71a1ea 61 fields · synced Jul 22, 2026
  • EUDAMED 7f950f8d-7bd2-43a2-a539-614c7c66e24d 61 fields · synced Jul 22, 2026
  • EUDAMED 49bf8f2e-1533-418c-8cb7-d40233ac9733 61 fields · synced Jul 22, 2026
  • EUDAMED d62e265f-9854-4987-8b4c-8b02fe8eb8e5 61 fields · synced Jul 22, 2026
  • EUDAMED 4ba3af3c-123b-43b1-874f-80839d2b200e 61 fields · synced Jul 27, 2026
  • EUDAMED a35c61db-3694-4b0d-8740-bec08a54dcd8 61 fields · synced Jul 28, 2026
  • EUDAMED a0c443f3-97ba-41dc-bb20-7f5bce12d328 61 fields · synced Jul 28, 2026
  • EUDAMED f83d7682-a6dd-4311-aba1-d22b9e60260d 61 fields · synced Jul 30, 2026