microINR ® CHIPS
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- microINR Chips EUDAMEDmicroINR ® CHIPS FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
- Device Name
- microINR Chips EUDAMED
- Model / Reference
- CHB0025AB-10 EUDAMEDCHB0025AU EUDAMEDCHC0025AD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436540291189 EUDAMED08436540290687 EUDAMED08436540290717 FDA UDI
- Basic UDI-DI
- B-08436540291189 EUDAMEDB-08436540290687 EUDAMED
- 510(k) Number
- K201185 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 devices for self-testing EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7750 FDA UDI
- Market of Registration
- Germany EUDAMEDHungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
Yes
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Prothrombin time (PT) IVD, kit, rapid clotting, clinical
microINR ® CHIPS by Iline Microsystems Sl — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Prothrombin time (PT) IVD, kit, rapid clotting, clinical.
- Assure PT Care Test Strip Kit — CoaguSense Inc. · Class II
- Coag-sense — CoaguSense Inc. · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- Drew — Drew Scientific , Ltd. · Class II
- Coag-sense — CoaguSense Inc. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Coag-sense — CoaguSense Inc. · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
Cleared under the same submission
K201185 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Iline Microsystems Sl
Sources (3)
- FDA UDI f88821bb-16b1-490b-8653-442d4c0a1e83 33 fields · synced Jul 25, 2026
- EUDAMED 0f447132-375d-49ce-b27b-c13ca58de199 61 fields · synced Jun 20, 2026
- EUDAMED 05386a52-304a-4ce1-8c85-14d64179931a 61 fields · synced Jul 25, 2026