Identity
- Trade Name
- Asserachrom® Washing Solution EUDAMEDFDA UDI
- Generic Name
- Buffered wash solution IVD, manual FDA UDI
- Device Name
- Washing Solution EUDAMED
- Model / Reference
- 00555 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 13607450005551 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607450AUXI0007RY EUDAMED
- Unit of Use DI
- 03607450005554 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W0103020903 BUFFERS (HAEMOSTASIS) EUDAMED
- GMDN Term
- Buffered wash solution IVD, manual FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- France 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
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Asserachrom® Washing Solution by Diagnostica Stago — 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 | 3607450AUXI0007RY | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED a61eff1c-6f27-457d-8620-927538a547e2 61 fields · synced Jun 20, 2026
- FDA UDI 55c476b0-5e83-4abd-ae41-355cfe276860 33 fields · synced May 29, 2026