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Thermo Scientific Sorvall X4RF Pro-MD

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 75009541

by Thermo Electron LED GmbH Zweigniederlassung Osterode

Identity

Trade Name
Thermo Scientific Sorvall X4RF Pro-MD EUDAMED
Thermo Scientific FDA UDI
Generic Name
General-purpose centrifuge IVD FDA UDI
Device Name
GP4 Pro EUDAMED
Sorvall X4RF Pro-MD 220-240V/50Hz, 230V/60Hz FDA UDI
Model / Reference
75009541 EUDAMED
Sorvall X4RF Pro-MD FDA UDI
Description
Sorvall X4RF Pro-MD 220-240V/50Hz, 230V/60Hz FDA UDI

Identifiers

Catalog Number
75009541 FDA UDI
Primary DI / UDI-DI
10850033408437 EUDAMEDFDA UDI
Basic UDI-DI
0850685007750095_IVD52 EUDAMED
Direct Marketing DI
10850033408437 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 EUDAMED
Class 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 X4RF 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

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Manufacturer

Manufacturer
Thermo Electron LED GmbH Zweigniederlassung Osterode
EUDAMED SRN
DE-MF-000008786

Sources (2)

  • EUDAMED c09fd715-c78d-4272-a5f7-1b54b5a5815d 61 fields · synced Jul 9, 2026
  • FDA UDI 7e5b039a-fad2-48dd-8620-47c2163b5cdc 35 fields · synced May 30, 2026