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AMYLASE Kit
EUDAMEDClass IVD General (EU MDR)
Ref B30026Model AMYLASE Kit 112mL Ref B34027Model AMYLASE Kit 250mLRef B21026Model Amylase 108 mLRef B34025Model AMYLASE Kit 150mLRef B28027Model AMYLASE Kit 100mLRef B33028Ref B27027Model AMYLASE Kit 100 mLRef B21029Model Amylase 240 mLRef B21025Model Amylase 324 mLRef B28028Ref B33026Model AMYLASE Kit 112mLRef B33027Ref B29026Ref B35027Model AMYLASE Kit 110mLRef B24025Model AMYLASE Kit 150mL Ref B27025Model AMYLASE Kit 336mL Ref B30028Ref B22025Model Amylase 115 mLRef B30027Ref B30025Model AMYLASE Kit 336mL
Identity
- Trade Name
- AMYLASE Kit EUDAMEDAmylase EUDAMED
- Device Name
- AMYLASE Kit EUDAMEDAmylase EUDAMED
- Model / Reference
- AMYLASE Kit 112mL EUDAMEDB30026 EUDAMEDAMYLASE Kit 250mL EUDAMEDB34027 EUDAMEDAmylase 108 mL EUDAMEDB21026 EUDAMEDAMYLASE Kit 150mL EUDAMEDB34025 EUDAMEDAMYLASE Kit 100mL EUDAMEDB28027 EUDAMEDB33028 EUDAMEDAMYLASE Kit 100 mL EUDAMEDB27027 EUDAMEDAmylase 240 mL EUDAMEDB21029 EUDAMEDAmylase 324 mL EUDAMEDB21025 EUDAMEDB28028 EUDAMEDB33026 EUDAMEDB33027 EUDAMEDB29026 EUDAMEDAMYLASE Kit 110mL EUDAMEDB35027 EUDAMEDB24025 EUDAMEDAMYLASE Kit 336mL EUDAMEDB27025 EUDAMEDB30028 EUDAMEDAmylase 115 mL EUDAMEDB22025 EUDAMEDB30027 EUDAMEDB30025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555613943 EUDAMED08683555616388 EUDAMED08683555610072 EUDAMED08683555616364 EUDAMED08683555618481 EUDAMED08683555615527 EUDAMED08683555612397 EUDAMED08683555601018 EUDAMED08683555610065 EUDAMED08683555618498 EUDAMED08683555615503 EUDAMED08683555615510 EUDAMED08683555601483 EUDAMED08683555619402 EUDAMED08683555613318 EUDAMED08683555612373 EUDAMED08683555613967 EUDAMED08683555611888 EUDAMED08683555613950 EUDAMED08683555613936 EUDAMED
- Basic UDI-DI
- B-08683555613943 EUDAMEDB-08683555616388 EUDAMEDB-08683555610072 EUDAMEDB-08683555616364 EUDAMEDB-08683555618481 EUDAMEDB-08683555615527 EUDAMEDB-08683555612397 EUDAMEDB-08683555601018 EUDAMEDB-08683555610065 EUDAMEDB-08683555618498 EUDAMEDB-08683555615503 EUDAMEDB-08683555615510 EUDAMEDB-08683555601483 EUDAMEDB-08683555619402 EUDAMEDB-08683555613318 EUDAMEDB-08683555612373 EUDAMEDB-08683555613967 EUDAMEDB-08683555611888 EUDAMEDB-08683555613950 EUDAMEDB-08683555613936 EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
AMYLASE Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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-08683555613943 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (20)
- EUDAMED 7aadab29-e766-49e3-be78-b558442dc609 61 fields · synced Oct 5, 2026
- EUDAMED 1394a0e6-222e-42ee-a9e2-a58028856733 61 fields · synced May 16, 2026
- EUDAMED e3c75a32-6527-486c-b209-d49957f842d4 61 fields · synced May 16, 2026
- EUDAMED 43065dce-173f-46b7-916e-cf97105bcbbe 61 fields · synced May 16, 2026
- EUDAMED 13f06ad2-0c40-4c4a-9b48-a7ca767f298f 61 fields · synced May 16, 2026
- EUDAMED 05bbfb95-9195-47f0-aeb8-1d99915c379f 61 fields · synced May 16, 2026
- EUDAMED 40d56101-aabe-4f34-aad7-d24a0dd3210a 61 fields · synced May 17, 2026
- EUDAMED 1f8d31ac-48b9-4380-9810-5f7cc7644740 61 fields · synced May 17, 2026
- EUDAMED 5649024f-30bd-46ba-a3e6-fa7456e25ae0 61 fields · synced May 17, 2026
- EUDAMED 9918f5a6-39a5-4396-971b-26d180db389e 61 fields · synced May 17, 2026
- EUDAMED 941f29f8-7d09-4066-a501-6705721d2c7a 61 fields · synced May 17, 2026
- EUDAMED 841b11ea-9d8b-4708-827b-34eb3d783cfc 61 fields · synced May 17, 2026
- EUDAMED 6312451c-ce6b-4b4d-a811-728154288025 61 fields · synced May 18, 2026
- EUDAMED 7fa4832f-a6b1-4618-8b7e-5c334ad54aba 61 fields · synced May 18, 2026
- EUDAMED b073017f-fcd3-4c7e-afc1-25f4769a9585 61 fields · synced May 18, 2026
- EUDAMED 9ca1ff1b-541d-4f15-86cc-5f3029116922 61 fields · synced May 18, 2026
- EUDAMED 74e4ab9b-8cf2-42bf-a2db-b0f29587bf1d 61 fields · synced May 18, 2026
- EUDAMED 89600ae3-9d66-48ba-be3b-a4a46b8275fa 61 fields · synced May 18, 2026
- EUDAMED 939c9e57-b499-4daa-bf03-549cfa10c691 61 fields · synced May 19, 2026
- EUDAMED 6dfc26f2-3275-4b4d-b6e1-ca824df2b527 61 fields · synced May 19, 2026