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Cs-2000
EUDAMEDClass A (EU MDR)
Ref 3014142Model CS-2000 CS-2000i Ref 3019011Model CS-1300B CS-1600Ref 3000093Model CS-600B CS-650 CS-680 CS-1200Ref 3001454Ref 3009595Model DR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-480Ref CS-2000Ref CS-1300ARef CS-T240PlusRef CS-2000i Ref CS-1200Ref CS-1600Ref CS-1300BRef CS-T180Ref CS-680Ref CS-300BRef CS-480
Identity
- Trade Name
- CS-2000 EUDAMEDCS-1600 EUDAMEDCS-1200 EUDAMEDCS-1300B EUDAMEDCS-T240 Auto-Chemistry Analyzer EUDAMEDAuto-Chemistry Analyzer EUDAMED
- Device Name
- Auto-Chemistry Analyzer EUDAMEDChemistry Analyzer EUDAMED
- Model / Reference
- CS-2000 CS-2000i EUDAMED3014142 EUDAMEDCS-1300B CS-1600 EUDAMED3019011 EUDAMEDCS-600B CS-650 CS-680 CS-1200 EUDAMED3000093 EUDAMED3001454 EUDAMEDDR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-480 EUDAMED3009595 EUDAMEDCS-2000 EUDAMEDCS-1300A EUDAMEDCS-T240Plus EUDAMEDCS-2000i EUDAMEDCS-1200 EUDAMEDCS-1600 EUDAMEDCS-1300B EUDAMEDCS-T180 EUDAMEDCS-680 EUDAMEDCS-300B EUDAMEDCS-480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794520029 EUDAMED06925794504883 EUDAMED06925794504739 EUDAMED06925794576125 EUDAMED06925794576064 EUDAMED06942202258602 EUDAMED06942202227578 EUDAMED06942202240744 EUDAMED06942202258596 EUDAMED06925794576170 EUDAMED06942202258640 EUDAMED06942202227608 EUDAMED06942202244049 EUDAMED06942202211447 EUDAMED06925794581587 EUDAMED06942202227585 EUDAMED06925794576033 EUDAMED06942202258435 EUDAMED06942202227592 EUDAMED06942202257940 EUDAMED06942202258480 EUDAMED06942202258442 EUDAMED06942202227547 EUDAMED06925794576057 EUDAMED06942202204173 EUDAMED06925794581600 EUDAMED06942202258657 EUDAMED06925794576071 EUDAMED06942202258473 EUDAMED06942202258367 EUDAMED06942202258619 EUDAMED06942202227554 EUDAMED06942202258510 EUDAMED06942202258589 EUDAMED06942202258633 EUDAMED06942202258411 EUDAMED06942202258343 EUDAMED06942202258350 EUDAMED06942202258497 EUDAMED06942202227615 EUDAMED06942202258398 EUDAMED
- Basic UDI-DI
- 69257945W0201010104D0JW EUDAMED69257945W0201010103D0JR EUDAMED69257945W0201010102D0JL EUDAMED69257945W0201010101D0JF EUDAMEDB-06942202258602 EUDAMEDB-06942202227578 EUDAMEDB-06942202240744 EUDAMEDB-06942202258596 EUDAMEDB-06925794576170 EUDAMEDB-06942202258640 EUDAMEDB-06942202227608 EUDAMEDB-06942202244049 EUDAMEDB-06925794504739 EUDAMEDB-06942202211447 EUDAMEDB-06925794581587 EUDAMEDB-06942202227585 EUDAMEDB-06925794576125 EUDAMEDB-06925794576033 EUDAMEDB-06942202258435 EUDAMEDB-06942202227592 EUDAMEDB-06942202257940 EUDAMEDB-06925794504883 EUDAMEDB-06942202258480 EUDAMEDB-06942202258442 EUDAMEDB-06942202227547 EUDAMEDB-06925794576057 EUDAMEDB-06942202204173 EUDAMEDB-06925794581600 EUDAMEDB-06942202258657 EUDAMEDB-06925794576071 EUDAMEDB-06942202258473 EUDAMEDB-06942202258367 EUDAMEDB-06942202258619 EUDAMEDB-06942202227554 EUDAMEDB-06942202258510 EUDAMEDB-06942202258589 EUDAMEDB-06942202258633 EUDAMEDB-06942202258411 EUDAMEDB-06942202258343 EUDAMEDB-06942202258350 EUDAMEDB-06942202258497 EUDAMEDB-06925794520029 EUDAMEDB-06942202227615 EUDAMEDB-06942202258398 EUDAMED
- EMDN Code
- W0201010104 CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200) EUDAMEDW0201010103 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200) EUDAMEDW0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) EUDAMEDW0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMEDW0201010108 CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200) EUDAMEDW0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200) EUDAMEDW0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400) EUDAMEDW0201010106 CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800) EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDItaly EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Cs-2000 by Dirui Industrial Co., Ltd — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69257945W0201010104D0JW | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 69257945W0201010104D0JW | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (45)
- EUDAMED 71f64872-b003-4aea-a479-c6f0ae204339 61 fields · synced Sep 18, 2026
- EUDAMED 80276ac5-87f4-4be5-9b2d-e5a8d8880e13 61 fields · synced May 17, 2026
- EUDAMED 2a0f61d9-53a6-44cd-aabd-89c121f92992 61 fields · synced May 17, 2026
- EUDAMED a1365582-2ccc-4990-823a-54e6262ee399 61 fields · synced May 18, 2026
- EUDAMED 68647fe1-feb1-450b-98bb-4e411b62570b 61 fields · synced May 18, 2026
- EUDAMED c9c52ca4-7414-475a-8595-a74890150b6e 61 fields · synced Jun 18, 2026
- EUDAMED f109ddea-a46c-455c-8fc9-183b61c23633 61 fields · synced Jun 20, 2026
- EUDAMED b09616d5-4b1a-4aa7-bafe-d028ca2fa65a 61 fields · synced Jul 9, 2026
- EUDAMED 4c514203-8a03-4ce1-9269-b3f309bf35da 61 fields · synced Jul 9, 2026
- EUDAMED 1b827838-d9f5-43e6-82a1-d69bf9ab1685 61 fields · synced Jul 9, 2026
- EUDAMED c18211a2-9cd8-47fc-8d0d-5e69eb4b0003 61 fields · synced Jul 9, 2026
- EUDAMED 90ad4a67-6fa0-439b-a698-d9d544acf8b5 61 fields · synced Jul 9, 2026
- EUDAMED 7aa626a1-1212-4175-b6ec-38afe8a47c96 61 fields · synced Jul 9, 2026
- EUDAMED 14ae9bb1-9cea-4b28-8002-a0690fb31996 61 fields · synced Jul 9, 2026
- EUDAMED 25057a2f-0615-4aea-9f51-7c5ede772e56 61 fields · synced Jul 10, 2026
- EUDAMED 7e905fc8-7073-4737-9a71-53d325757fba 61 fields · synced Jul 10, 2026
- EUDAMED 8ec812d9-6a6e-4e4c-bf7c-7db2384ebb1f 61 fields · synced Jul 11, 2026
- EUDAMED b46d683c-711c-4ce0-8efe-fff0589b1cf8 61 fields · synced Jul 11, 2026
- EUDAMED 81da7421-32a1-4d1b-883d-edc32ff8c50f 61 fields · synced Jul 12, 2026
- EUDAMED 4713dda3-43e7-4f5c-8e03-fad14e79f881 61 fields · synced Jul 14, 2026
- EUDAMED 98107864-cf1c-4df5-9b56-c83fbf4363de 61 fields · synced Jul 15, 2026
- EUDAMED ae4a2b4f-a485-4115-a78b-dbdf26c73be8 61 fields · synced Jul 15, 2026
- EUDAMED a45cd322-4efe-44bd-aa90-65eaaf29e500 61 fields · synced Jul 17, 2026
- EUDAMED 643f8878-902f-4c9d-98c4-f32365da5cf2 61 fields · synced Jul 17, 2026
- EUDAMED 3399e532-edc1-4ffe-add2-d38c535621da 61 fields · synced Jul 17, 2026
- EUDAMED b83c401f-677c-4cc2-a6d1-d04549680530 61 fields · synced Jul 18, 2026
- EUDAMED bc26309f-4114-450e-ac8d-15f00adaad3f 61 fields · synced Jul 20, 2026
- EUDAMED 12e36554-6aea-4a08-b469-a40e227f93b9 61 fields · synced Jul 21, 2026
- EUDAMED 0f331672-c444-46e8-a43d-5d21780aa432 61 fields · synced Jul 22, 2026
- EUDAMED 96660026-90fe-40da-97ee-9c118219ab73 61 fields · synced Jul 26, 2026
- EUDAMED e7b5f3ec-df94-43af-9e45-519cffc244c4 61 fields · synced Jul 27, 2026
- EUDAMED c5bf7c89-85f0-4856-a2aa-94a54006678f 61 fields · synced Jul 29, 2026
- EUDAMED 9f301150-963f-47f1-ad51-9391aaa32197 61 fields · synced Jul 30, 2026
- EUDAMED 33395c4b-1a2c-473d-8dc7-49e9dcd88485 61 fields · synced Jul 31, 2026
- EUDAMED ab21926f-580b-4ed2-90ff-acae0aeaeb6f 61 fields · synced Jul 31, 2026
- EUDAMED 7611fef6-4ac5-487e-82ae-e91a4c9a2589 61 fields · synced Aug 2, 2026
- EUDAMED c6825874-a430-4f68-90c2-21cf02b4e4ca 61 fields · synced Aug 3, 2026
- EUDAMED 0ae5d1b8-fb17-4c11-9544-985bc316b79f 61 fields · synced Aug 3, 2026
- EUDAMED e8aaddab-0c70-4355-b30e-ac6472960801 61 fields · synced Aug 3, 2026
- EUDAMED 563b16a8-891a-425f-a09c-88d806c0c844 61 fields · synced Aug 4, 2026
- EUDAMED ada40184-ec61-41a2-919e-d74802463c54 61 fields · synced Sep 17, 2026
- EUDAMED 0c41504a-cb8f-4d2a-8263-b808f66fc68e 61 fields · synced Sep 17, 2026
- EUDAMED 900da912-31f1-4d81-a38e-be6aa158578a 61 fields · synced Sep 18, 2026
- EUDAMED fb42d411-cf00-4af1-a437-777737617667 61 fields · synced Sep 18, 2026
- EUDAMED b5b4f3c7-c0a0-4ddf-9681-6a7036e60730 61 fields · synced Sep 18, 2026