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Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit
EUDAMEDClass IVD General (EU MDR)
Ref 03P57-50Model 200209
Identity
- Trade Name
- Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit EUDAMED
- Device Name
- Coag-Sense Prothrombin Time (PT)/INR Test Strip, 50 Count EUDAMED
- Model / Reference
- 200209 EUDAMED03P57-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850040656091 EUDAMED
- Basic UDI-DI
- B-00850040656091 EUDAMED
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit by CoaguSense Inc. — 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-00850040656091 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CoaguSense Inc.
- EUDAMED SRN
- US-MF-000026989
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1f625fc6-a73b-43d7-b503-7e92df4eaf82 61 fields · synced Jun 18, 2026