Identity
- Trade Name
- Thermo Scientific X4TR IVD-MD EUDAMED
- Device Name
- GP4 Pro EUDAMED
- Model / Reference
- 75007365 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850044310132 EUDAMED
- Basic UDI-DI
- 0850685007750095_IVD52 EUDAMED
- Direct Marketing DI
- 10850044310132 EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Thermo Scientific X4TR IVD-MD by Thermo Electron LED GmbH Zweigniederlassung Osterode — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Thermo Fisher Scientific Logo
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850685007750095_IVD52 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermo Electron LED GmbH Zweigniederlassung Osterode
- EUDAMED SRN
- DE-MF-000008786
Sources (1)
- EUDAMED 08a4ff2b-7f9c-41d4-8a42-3ea7435f2ac4 61 fields · synced Aug 1, 2026