← Back to catalogue
Lc-40d Xr Cl
EUDAMEDFDA UDIClass A (EU MDR)
Ref 228-65000-55Model SOLVENT DELIVERY MODULE
Identity
- Trade Name
- LC-40D XR CL EUDAMEDFDA UDI
- Generic Name
- High performance liquid chromatography analyser IVD FDA UDI
- Model / Reference
- SOLVENT DELIVERY MODULE EUDAMED228-65000-55 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217420568 EUDAMEDFDA UDI
- Basic UDI-DI
- 454021742000000000000093A EUDAMED
- FDA Product Code
- KIE FDA UDI
- EMDN Code
- W0201050201,W020303 EUDAMED
- GMDN Term
- High performance liquid chromatography analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2260 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Lc-40d Xr Cl by Shimadzu 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 | 454021742000000000000093A | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 7411fba9-fac2-4b97-85f7-ad02aeae1e2d 61 fields · synced Jul 31, 2026
- FDA UDI 43db8108-07d6-4b15-b899-ae34cb8be6b0 32 fields · synced May 30, 2026