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Coag-Sense Prothrombin Time (PT) /INR Monitoring System
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 03P70-02Model 200222
Identity
- Trade Name
- Coag-Sense Prothrombin Time (PT) /INR Monitoring System EUDAMEDCoag-Sense PT/INR Professional System FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
- Device Name
- Coag-Sense Prothrombin Time (PT)/INR Monitoring System Professional Use EUDAMEDCoag-Sense PT/INR Professional System FDA UDI
- Model / Reference
- 200222 EUDAMEDFDA UDI03P70-02 EUDAMED
- Description
- Coag-Sense PT/INR Professional System FDA UDI
Identifiers
- Catalog Number
- 03P70-02 FDA UDI
- Primary DI / UDI-DI
- 00861900000374 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00861900000374 EUDAMED
- FDA Product Code
- GJS FDA UDI
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
- GMDN Term
- Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7750 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Coag-Sense Prothrombin Time (PT) /INR Monitoring System by CoaguSense Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00861900000374 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- CoaguSense Inc.
- EUDAMED SRN
- US-MF-000026989
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d0ef3a32-38a4-479f-a691-a6cfaed8d640 61 fields · synced Jun 20, 2026
- FDA UDI 628437ac-b775-4aee-a32e-ca68d0c42598 36 fields · synced May 30, 2026