Identity
- Trade Name
- μTASWako Wash Solution EUDAMEDuTASWako Wash Solution FDA UDI
- Generic Name
- Immunohistochemistry wash buffer reagent IVD FDA UDI
- Device Name
- μTASWako Wash Solution EUDAMEDIn-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 991-60801 EUDAMEDFDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 991-60801 FDA UDI
- Primary DI / UDI-DI
- 14987481164502 EUDAMEDFDA UDI
- Basic UDI-DI
- 498748114987481164502Z3 EUDAMED
- 510(k) Number
- K100464 FDA UDI
- FDA Product Code
- NSF FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Immunohistochemistry wash buffer reagent IVD FDA UDI
Classification
- Device Class
- Class A 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
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
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
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
μTASWako Wash Solution by Fujifilm Wako Pure Chemical Corporation — Class A — 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 | 498748114987481164502Z3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 (3)
- EUDAMED 6a097e09-ef1e-4763-b101-11a86c7755f9 61 fields · synced Oct 6, 2026
- FDA UDI efb8bc44-c920-417e-aeb8-039a310b5521 37 fields · synced May 30, 2026
- EUDAMED ca6582e0-0d6e-4f39-bfd9-3020e71c8f48 61 fields · synced Jul 23, 2026