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μTASWako DCP
EUDAMEDFDA UDIClass C (EU MDR)
Ref 995-60701Model 995-60701, 999-61201, 995-61301, 991-61401
Identity
- Trade Name
- μTASWako DCP EUDAMEDuTASWako DCP FDA UDI
- Generic Name
- Des-gamma-carboxyprothrombin (DCP) IVD, reagent FDA UDI
- Device Name
- μTASWako DCP, μTASWako DCP Calibrator Set, μTASWako DCP Control L, μTASWako DCP Control H EUDAMEDIn-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 995-60701, 999-61201, 995-61301, 991-61401 EUDAMED995-60701 EUDAMEDFDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 995-60701 FDA UDI
- Primary DI / UDI-DI
- 04987481164413 EUDAMEDFDA UDI
- Basic UDI-DI
- 49874814987481164413UA EUDAMED
- 510(k) Number
- K100464 FDA UDI
- FDA Product Code
- OAU FDA UDI
- EMDN Code
- W0102039017 PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II) EUDAMED
- GMDN Term
- Des-gamma-carboxyprothrombin (DCP) IVD, reagent FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.6030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
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
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
μTASWako DCP by Fujifilm Wako Pure Chemical Corporation — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 49874814987481164413UA | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Wako Pure Chemical Corporation
- EUDAMED SRN
- JP-MF-000013944
- Authorised Representative
- FUJIFILM Wako Chemicals Europe GmbH DE-AR-000011552
Sources (2)
- EUDAMED 0103b6f0-5470-4313-a014-2fcde9d7ba58 61 fields · synced Jun 18, 2026
- FDA UDI 3cd316f9-b52e-4ff2-814b-e50e606b8c49 37 fields · synced May 30, 2026