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α-Amylase Assay Kit (EPS Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH070207Model R1: 60 mL×1; R2: 15 mL×1
Identity
- Device Name
- α-Amylase Assay Kit (EPS Method) EUDAMED
- Model / Reference
- R1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH070207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460677 EUDAMED
- Basic UDI-DI
- B-06975225460677 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-06975225460677 | 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 (1)
- EUDAMED fe8bb543-73b6-4d67-8854-c9b1b03fd81d 61 fields · synced Jun 18, 2026