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α-Amylase (AMY) Test Kit (EPS-G7)
EUDAMEDClass IVD General (EU MDR)
Ref R1:50mL×1 R2:18mL×1（706）
Identity
- Trade Name
- α-Amylase (AMY) Test Kit (EPS-G7) EUDAMED
- Device Name
- α-Amylase (AMY) Test Kit (EPS-G7) EUDAMED
- Model / Reference
- R1:50mL×1 R2:18mL×1（706） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674864684 EUDAMED
- Basic UDI-DI
- B-06971674864684 EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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 (AMY) Test Kit (EPS-G7) by Biobase Biodustry(Shandong) 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-06971674864684 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 1b7402c6-663f-4b88-a8d8-d1b47bb42cac 61 fields · synced Jun 18, 2026