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Cystatin C Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030501Model R1: 60 mL×3; R2: 20 mL×3Ref DTSH030507CModel R1: 45 mL×3; R2: 45 mL×1; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2Ref DTSH030506Model R1: 80 mL×3; R2: 20 mL×4Ref DTSH030503Model R1: 60 mL×1; R2: 20 mL×1Ref DTSH030506CModel R1: 80 mL×3; R2: 20 mL×4; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2Ref DTSH030507Model R1: 45 mL×3; R2: 45 mL×1Ref DTSH030501CModel R1: 60 mL×3; R2: 20 mL×3; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2Ref DTSH030502Model R1: 21 mL×1; R2: 7 mL×1Ref DTSH030502CModel R1: 21 mL×1; R2: 7 mL×1; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2
Identity
- Device Name
- Cystatin C Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 60 mL×3; R2: 20 mL×3 EUDAMEDDTSH030501 EUDAMEDR1: 45 mL×3; R2: 45 mL×1; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2 EUDAMEDDTSH030507C EUDAMEDR1: 80 mL×3; R2: 20 mL×4 EUDAMEDDTSH030506 EUDAMEDR1: 60 mL×1; R2: 20 mL×1 EUDAMEDDTSH030503 EUDAMEDR1: 80 mL×3; R2: 20 mL×4; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2 EUDAMEDDTSH030506C EUDAMEDR1: 45 mL×3; R2: 45 mL×1 EUDAMEDDTSH030507 EUDAMEDR1: 60 mL×3; R2: 20 mL×3; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2 EUDAMEDDTSH030501C EUDAMEDR1: 21 mL×1; R2: 7 mL×1 EUDAMEDDTSH030502 EUDAMEDR1: 21 mL×1; R2: 7 mL×1; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2 EUDAMEDDTSH030502C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463227 EUDAMED06975225463210 EUDAMED06975225463265 EUDAMED06975225463180 EUDAMED06975225463272 EUDAMED06975225463203 EUDAMED06975225463234 EUDAMED06975225463166 EUDAMED06975225463173 EUDAMED
- Basic UDI-DI
- B-06975225463227 EUDAMEDB-06975225463210 EUDAMEDB-06975225463265 EUDAMEDB-06975225463180 EUDAMEDB-06975225463272 EUDAMEDB-06975225463203 EUDAMEDB-06975225463234 EUDAMEDB-06975225463166 EUDAMEDB-06975225463173 EUDAMED
- EMDN Code
- W0102019008 CYSTATIN C EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Cystatin C Assay Kit (Latex Immunoturbidimetric Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975225463227 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (9)
- EUDAMED 1f8ed303-3405-4982-99ff-530a24c83407 61 fields · synced Jul 30, 2026
- EUDAMED e62f630e-efc9-4474-b3c2-a712b2501f3a 61 fields · synced May 16, 2026
- EUDAMED 35bf7968-4089-4204-9047-dbabe914d71c 61 fields · synced May 16, 2026
- EUDAMED 2ac9cfe9-c4b5-4901-959b-cab955713b54 61 fields · synced May 17, 2026
- EUDAMED ecff19f5-b91f-473b-949f-f8886f461875 61 fields · synced May 17, 2026
- EUDAMED b0476f54-d963-414e-8a28-8ee14ac81d32 61 fields · synced May 17, 2026
- EUDAMED 9cbd2c24-8bc4-4f92-9b75-570a87c7de84 61 fields · synced May 17, 2026
- EUDAMED 284ddd22-3ee5-4a5b-8fec-64b33b04155a 61 fields · synced May 18, 2026
- EUDAMED c34d1151-8fc3-4cbe-af0a-c1581405f3ec 61 fields · synced May 18, 2026