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Dgu-405 Cl
EUDAMEDFDA UDIClass A (EU MDR)
Ref 228-65019-55Model DEGASSING UNITRef 228-65089-55
Identity
- Trade Name
- DGU-405 CL EUDAMEDFDA UDI
- Generic Name
- High performance liquid chromatography analyser IVD FDA UDI
- Model / Reference
- DEGASSING UNIT EUDAMED228-65019-55 EUDAMEDFDA UDI228-65089-55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217420537 EUDAMEDFDA UDI04540217420704 EUDAMED
- Basic UDI-DI
- 4540217420000000000001637 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
Dgu-405 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 | 4540217420000000000001637 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 0cf407f2-d6a7-44ef-bbc5-9c04a49a6f29 61 fields · synced Jul 24, 2026
- EUDAMED abcbde29-a404-4780-b526-3aa519e81a7d 61 fields · synced May 18, 2026
- FDA UDI e56decc5-04d6-47ad-9b6f-6ea4510323e2 32 fields · synced May 30, 2026