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α-Amylase (AMY) Test Kit (EPS-G7)
EUDAMEDClass IVD General (EU MDR)
Ref R1:50mL×1 R2:18mL×1（715）Ref R1:50mL×1 R2:18mL×1（705）Ref R1:50mL×1 R2:18mL×1（798）Ref R1:25mL×4 R2:9mL×4（709）Ref R1:50mL×6 R2:54mL×2（795）Ref R1:100mL×1 R2:36mL×1（708）Ref R1:25mL×1 R2:9mL×1（702）Ref R1:50mL×1 R2:18mL×1（791）Ref R1:50mL×1 R2:18mL×1（701）
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（715） EUDAMEDR1:50mL×1 R2:18mL×1（705） EUDAMEDR1:50mL×1 R2:18mL×1（798） EUDAMEDR1:25mL×4 R2:9mL×4（709） EUDAMEDR1:50mL×6 R2:54mL×2（795） EUDAMEDR1:100mL×1 R2:36mL×1（708） EUDAMEDR1:25mL×1 R2:9mL×1（702） EUDAMEDR1:50mL×1 R2:18mL×1（791） EUDAMEDR1:50mL×1 R2:18mL×1（701） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674864752 EUDAMED06971674864677 EUDAMED06971674864738 EUDAMED06971674864646 EUDAMED06971674864721 EUDAMED06971674864691 EUDAMED06971674864653 EUDAMED06971674864707 EUDAMED06971674864639 EUDAMED
- Basic UDI-DI
- B-06971674864752 EUDAMEDB-06971674864677 EUDAMEDB-06971674864738 EUDAMEDB-06971674864646 EUDAMEDB-06971674864721 EUDAMEDB-06971674864691 EUDAMEDB-06971674864653 EUDAMEDB-06971674864707 EUDAMEDB-06971674864639 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-06971674864752 | 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 (9)
- EUDAMED f7935432-de86-4ad4-b872-ded1c624b63f 61 fields · synced Oct 6, 2026
- EUDAMED 45421f78-99ad-4615-87df-3c58b21dfb24 61 fields · synced May 16, 2026
- EUDAMED 953ad338-4b81-4a9f-8be5-dc2288c3ca04 61 fields · synced May 17, 2026
- EUDAMED 2cb06267-c26a-486f-9292-416b3c8fdc26 61 fields · synced May 17, 2026
- EUDAMED 756d7b5a-a093-4379-a7cc-e921bf6cc146 61 fields · synced May 17, 2026
- EUDAMED dedeeb9b-321b-427d-9b63-34382b2cb05f 61 fields · synced May 17, 2026
- EUDAMED ab48e5af-c886-4d8f-ad43-5ea1a784a872 61 fields · synced May 18, 2026
- EUDAMED 664c7eda-ce1a-4b2b-9b6f-7252bb1f8d73 61 fields · synced May 19, 2026
- EUDAMED a73a925e-a248-45b6-b9aa-88a326bf9ccd 61 fields · synced May 19, 2026