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Alkaline Phosphatase (4+1) (Kinetic IFCC Method)
EUDAMEDClass IVD General (EU MDR)
Ref D-602 005Ref D-602 001Ref D-602 004
Identity
- Trade Name
- Alkaline Phosphatase (4+1) (Kinetic IFCC Method) EUDAMED
- Device Name
- Alkaline Phosphatase (4+1) (Kinetic IFCC Method) EUDAMED
- Model / Reference
- D-602 005 EUDAMEDD-602 001 EUDAMEDD-602 004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182707132 EUDAMED62230182706838 EUDAMED62230182707064 EUDAMED
- Basic UDI-DI
- B-62230182707132 EUDAMEDB-62230182706838 EUDAMEDB-62230182707064 EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - 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
Alkaline Phosphatase (4+1) (Kinetic IFCC Method) by Kalians Corporation — 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-62230182707132 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 30eb128f-90b0-4fd5-bc2d-cf2cf422f7da 61 fields · synced Jul 25, 2026
- EUDAMED 266282a7-c6ed-417f-a274-835359787dc5 61 fields · synced May 17, 2026
- EUDAMED cc386b12-824a-4b0c-a073-22a953d82f1c 61 fields · synced May 18, 2026