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PT Reagent ISI 1.5
EUDAMEDClass IVD General (EU MDR)
Ref D-707 001Ref D-707 002
Identity
- Trade Name
- PT Reagent ISI 1.5 EUDAMED
- Device Name
- PT Reagent ISI 1.5 EUDAMED
- Model / Reference
- D-707 001 EUDAMEDD-707 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182716806 EUDAMED62230182716974 EUDAMED
- Basic UDI-DI
- B-62230182716806 EUDAMEDB-62230182716974 EUDAMED
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
PT Reagent ISI 1.5 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-62230182716806 | 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 (2)
- EUDAMED b7e9b947-3936-4c98-8242-727943769b0a 61 fields · synced Jul 23, 2026
- EUDAMED 87462dd4-610c-45b7-95f6-7dfa313ef6e2 61 fields · synced May 19, 2026