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Coag-Sense Control Test Strip Kit - 10 Count
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 03P69-10
Identity
- Trade Name
- Coag-Sense Control Test Strip Kit - 10 Count EUDAMEDCoag-sense FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
- Device Name
- Coag-Sense Control Test Strip Kit - 10 Count EUDAMEDCoag-Sense Professional Control Test Strip Kit - 10 Ct FDA UDI
- Model / Reference
- 03P69-10 EUDAMED100250 FDA UDI
- Description
- Coag-Sense Professional Control Test Strip Kit - 10 Ct FDA UDI
Identifiers
- Catalog Number
- 03P69-10 FDA UDI
- Primary DI / UDI-DI
- 00850040656138 EUDAMED00861900000343 FDA UDI
- Basic UDI-DI
- B-00850040656138 EUDAMED
- 510(k) Number
- K093243 FDA UDI
- FDA Product Code
- GJS FDA UDI
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) 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
Yes
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
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 Control Test Strip Kit - 10 Count 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-00850040656138 | 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 db34b1a2-372e-40a9-81f7-2cb0d327e02e 61 fields · synced Jul 17, 2026
- FDA UDI 1f37f053-a2d0-4005-b719-d41b869322f6 37 fields · synced May 29, 2026