Identity
- Trade Name
- LCMS-8050 CL EUDAMEDFDA UDI
- Generic Name
- Mass spectrometry analyser IVD FDA UDI
- Device Name
- Liquid Chromatograph Mass Spectrometer EUDAMED
- Model / Reference
- 225-19610-55 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217400720 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217400720 EUDAMED
- FDA Product Code
- DOP FDA UDI
- EMDN Code
- W020303 MASS - SPECTROMETRY SYSTEM EUDAMED
- GMDN Term
- Mass spectrometry analyser IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2860 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
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Lcms-8050 Cl by Shimadzu Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-04540217400720 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (2)
- EUDAMED 0722e6ea-20d7-4c7d-a75f-4c396b21db32 61 fields · synced May 30, 2026
- FDA UDI ee3c8902-82ce-49b2-8bb9-a41e42079860 32 fields · synced May 30, 2026