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Amylase Reagent Kit（ifcc Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000812Model R1: 2x60mL, R2: 2x15mLRef 3000814Model R1: 4x50mL, R2: 2x25mLRef 3016503Ref 3016499Ref 3023199
Identity
- Trade Name
- AMYLASE REAGENT KIT（IFCC METHOD） EUDAMED
- Device Name
- AMYLASE REAGENT KIT（IFCC METHOD） EUDAMED
- Model / Reference
- R1: 2x60mL, R2: 2x15mL EUDAMED3000812 EUDAMEDR1: 4x50mL, R2: 2x25mL EUDAMED3000814 EUDAMED3016503 EUDAMED3016499 EUDAMED3023199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261275 EUDAMED06942202257469 EUDAMED06942202261251 EUDAMED06942202261244 EUDAMED06942202212888 EUDAMED
- Basic UDI-DI
- B-06942202261275 EUDAMEDB-06942202257469 EUDAMEDB-06942202261251 EUDAMEDB-06942202261244 EUDAMEDB-06942202212888 EUDAMED
- EMDN Code
- W01010108 AMYLASE ISOENZYMES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Amylase Reagent Kit（ifcc Method） by Dirui Industrial 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-06942202261275 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 947053ff-49b6-41d4-96bb-fd6174590aa7 61 fields · synced Aug 1, 2026
- EUDAMED b222c5f5-08c6-41de-9e5a-c3ead0746f58 61 fields · synced May 17, 2026
- EUDAMED 4cb0a097-19b4-4d0b-a05b-6676cf4beba4 61 fields · synced Jul 8, 2026
- EUDAMED b8899818-d611-451f-9c80-735adc2663d4 61 fields · synced Jul 18, 2026
- EUDAMED c8a4db7c-cf42-4b9f-968e-8ed349fe2915 61 fields · synced Aug 1, 2026