Thermo Scientific Sorvall X4 Pro-MD
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Thermo Scientific Sorvall X4 Pro-MD EUDAMEDThermo Scientific FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- GP4 Pro EUDAMEDSorvall X4 Pro-MD 208-240V/50/60Hz FDA UDI
- Model / Reference
- 75009505 EUDAMEDSorvall X4 Pro-MD FDA UDI
- Description
- Sorvall X4 Pro-MD 208-240V/50/60Hz FDA UDI
Identifiers
- Catalog Number
- 75009505 FDA UDI
- Primary DI / UDI-DI
- 10850033408208 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850685007750095_IVD52 EUDAMED
- Direct Marketing DI
- 10850033408208 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069003 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose centrifuge IVD
Thermo Scientific Sorvall X4 Pro-MD by Thermo Electron LED GmbH Zweigniederlassung Osterode — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Manufacturer's product page: Thermo Fisher Scientific Logo
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
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 e5099519-3dec-45c9-9fb9-61178d414738 61 fields · synced Jun 17, 2026
- FDA UDI 120f73bc-da5f-492f-8d01-eb4dfb6b906d 35 fields · synced May 30, 2026