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Lipase Assay Kit (Methylresorufin Substrate Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH070101CModel R1: 40 mL×4; R2: 20 mL×4 Calibrator: 3 mL × 1Ref DTSH070102Model R1: 20 mL×1; R2: 10 mL×1Ref DTSH070102CModel R1: 20 mL×1; R2: 10 mL×1 Calibrator: 3 mL × 1Ref DTSH070104CModel R1: 40 mL×2; R2: 20 mL×2 Calibrator: 3 mL × 1Ref DTSH070105CModel R1: 60 mL×2; R2: 60 mL×1 Calibrator: 3 mL × 1Ref DTSH070103CModel R1: 50 mL×1; R2: 25 mL×1 Calibrator: 3 mL × 1Ref DTSH070103Model R1: 50 mL×1; R2: 25 mL×1
Identity
- Device Name
- Lipase Assay Kit (Methylresorufin Substrate Method) EUDAMED
- Model / Reference
- R1: 40 mL×4; R2: 20 mL×4 Calibrator: 3 mL × 1 EUDAMEDDTSH070101C EUDAMEDR1: 20 mL×1; R2: 10 mL×1 EUDAMEDDTSH070102 EUDAMEDR1: 20 mL×1; R2: 10 mL×1 Calibrator: 3 mL × 1 EUDAMEDDTSH070102C EUDAMEDR1: 40 mL×2; R2: 20 mL×2 Calibrator: 3 mL × 1 EUDAMEDDTSH070104C EUDAMEDR1: 60 mL×2; R2: 60 mL×1 Calibrator: 3 mL × 1 EUDAMEDDTSH070105C EUDAMEDR1: 50 mL×1; R2: 25 mL×1 Calibrator: 3 mL × 1 EUDAMEDDTSH070103C EUDAMEDR1: 50 mL×1; R2: 25 mL×1 EUDAMEDDTSH070103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463470 EUDAMED06975225463401 EUDAMED06975225463418 EUDAMED06975225463456 EUDAMED06975225463494 EUDAMED06975225463432 EUDAMED06975225463425 EUDAMED
- Basic UDI-DI
- B-06975225463470 EUDAMEDB-06975225463401 EUDAMEDB-06975225463418 EUDAMEDB-06975225463456 EUDAMEDB-06975225463494 EUDAMEDB-06975225463432 EUDAMEDB-06975225463425 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) 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
Category: Apolipoprotein B (Apo B) IVD, reagent
Lipase Assay Kit (Methylresorufin Substrate Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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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-06975225463470 | 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 (7)
- EUDAMED 18504db3-e187-47bd-b43e-b59919072b28 61 fields · synced Aug 5, 2026
- EUDAMED 27e0c5d5-6e9d-4553-b067-ebd4686a7b60 61 fields · synced May 18, 2026
- EUDAMED 23498577-7ccf-421e-bfc4-931511b90701 61 fields · synced May 18, 2026
- EUDAMED 5f0caa4c-fddb-4438-8a86-352febb42639 61 fields · synced May 18, 2026
- EUDAMED 8e3ff188-011e-4035-8248-970b7582c038 61 fields · synced May 18, 2026
- EUDAMED 4fcbb6f3-98a9-4871-b6cc-669b9e2c43a8 61 fields · synced May 18, 2026
- EUDAMED 6ea07f91-b70a-4dbc-b545-f5b54a8c4bab 61 fields · synced May 19, 2026