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α-Amylase Assay Kit (EPS Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH070206Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH070201Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH070205Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH070203Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH070210Model R1: 60 mL×4; R2: 60 mL×1
Identity
- Device Name
- α-Amylase Assay Kit (EPS Method) EUDAMED
- Model / Reference
- R1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH070206 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH070201 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH070205 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH070203 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH070210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460660 EUDAMED06975225460707 EUDAMED06975225460653 EUDAMED06975225460721 EUDAMED06975225460714 EUDAMED
- Basic UDI-DI
- B-06975225460660 EUDAMEDB-06975225460707 EUDAMEDB-06975225460653 EUDAMEDB-06975225460721 EUDAMEDB-06975225460714 EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL 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
α-Amylase Assay Kit (EPS Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975225460660 | 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 (5)
- EUDAMED b8059d9f-fd08-495a-8016-11b6c6cadb73 61 fields · synced Sep 18, 2026
- EUDAMED dd8ec185-13c2-4180-95a6-1bdef7dfe7d5 61 fields · synced May 17, 2026
- EUDAMED 6e2a0b2c-06bc-4ddb-8ac6-4ea7a7095e47 61 fields · synced May 17, 2026
- EUDAMED 3b551ed4-152a-49f1-b73d-64cbfe0c8f23 61 fields · synced May 18, 2026
- EUDAMED 97826d66-bb55-44b7-8ed5-ef6e5b1e4525 61 fields · synced May 18, 2026