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Thermo Scientific Sorvall X4R Pro-MD
EUDAMEDFDA UDIClass A (EU MDR)
Ref 75009520
Identity
- Trade Name
- Thermo Scientific Sorvall X4R Pro-MD EUDAMEDThermo Scientific FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- GP4 Pro EUDAMEDSorvall X4R Pro-MD 220-240/230V/50/60Hz FDA UDI
- Model / Reference
- 75009520 EUDAMEDSorvall X4R Pro-MD FDA UDI
- Description
- Sorvall X4R Pro-MD 220-240/230V/50/60Hz FDA UDI
Identifiers
- Catalog Number
- 75009520 FDA UDI
- Primary DI / UDI-DI
- 10850033408307 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850685007750095_IVD52 EUDAMED
- Direct Marketing DI
- 10850033408307 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Thermo Scientific Sorvall X4R Pro-MD by Thermo Electron LED GmbH Zweigniederlassung Osterode — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Manufacturer's product page: Thermo Fisher Scientific Logo
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 | 0850685007750095_IVD52 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Thermo Electron LED GmbH Zweigniederlassung Osterode
- EUDAMED SRN
- DE-MF-000008786
Sources (2)
- EUDAMED 44683281-a208-4215-b8aa-97d04bd78cc0 61 fields · synced Jun 18, 2026
- FDA UDI a2b2d0c8-a0e3-4e8d-8abc-be82f312eff9 35 fields · synced May 30, 2026