EUDAMED last updated this device on May 22, 2026

Thermo Scientific X4FR IVD-MD

0850685007750095_IVD52

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Thermo Electron LED GmbH Zweigniederlassung Osterode
UDI-DI code: 10850044310118
Reference / catalog number: 75007361

Thermo Scientific X4FR IVD-MD is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Thermo Electron LED GmbH Zweigniederlassung Osterode. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 22, 2026

Thermo Scientific X4FR IVD-MD

0850685007750095_IVD52

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Thermo Electron LED GmbH Zweigniederlassung Osterode
UDI-DI code: 10850044310118
Reference / catalog number: 75007361

View device family (Basic UDI)

Device identification

Trade name: Thermo Scientific X4FR IVD-MD
UDI-DI code: 10850044310118
Basic UDI-DI: 0850685007750095_IVD52
Reference / catalog number: 75007361
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)10850044310118

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W02069005REFRIGERATED CENTRIFUGES

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Germany; available across 32 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 21, 2025	Still on market
Austria	Nov 21, 2025	Still on market
Belgium	Nov 21, 2025	Still on market
Bulgaria	Nov 21, 2025	Still on market
Cyprus	Nov 21, 2025	Still on market
Czechia	Nov 21, 2025	Still on market
Denmark	Nov 21, 2025	Still on market
Estonia	Nov 21, 2025	Still on market
EL	Nov 21, 2025	Still on market
Spain	Nov 21, 2025	Still on market
Finland	Nov 21, 2025	Still on market
France	Nov 21, 2025	Still on market
Croatia	Nov 21, 2025	Still on market
Hungary	Nov 21, 2025	Still on market
Ireland	Nov 21, 2025	Still on market
Iceland	Nov 21, 2025	Still on market
Italy	Nov 21, 2025	Still on market
Liechtenstein	Nov 21, 2025	Still on market
Lithuania	Nov 21, 2025	Still on market
Luxembourg	Nov 21, 2025	Still on market
Latvia	Nov 21, 2025	Still on market
Malta	Nov 21, 2025	Still on market
Netherlands	Nov 21, 2025	Still on market
Norway	Nov 21, 2025	Still on market
Poland	Nov 21, 2025	Still on market
Portugal	Nov 21, 2025	Still on market
Romania	Nov 21, 2025	Still on market
Sweden	Nov 21, 2025	Still on market
Slovenia	Nov 21, 2025	Still on market
Slovakia	Nov 21, 2025	Still on market
Türkiye	Nov 21, 2025	Still on market
XI	Nov 21, 2025	Still on market

Device identification

Trade name: Thermo Scientific X4FR IVD-MD
UDI-DI code: 10850044310118
Basic UDI-DI: 0850685007750095_IVD52
Reference / catalog number: 75007361
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Thermo Electron LED GmbH Zweigniederlassung Osterode
SRN: DE-MF-000008786
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)10850044310118

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W02069005REFRIGERATED CENTRIFUGES

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

G10 057902 0002Issued
Quality management systemNotified body: 0123Expiry: Nov 19, 2028

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Thermo Electron LED GmbH Zweigniederlassung Osterode

Market distribution

Primary placement in Germany; available across 32 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 21, 2025	Still on market
Austria	Nov 21, 2025	Still on market
Belgium	Nov 21, 2025	Still on market
Bulgaria	Nov 21, 2025	Still on market
Cyprus	Nov 21, 2025	Still on market
Czechia	Nov 21, 2025	Still on market
Denmark	Nov 21, 2025	Still on market
Estonia	Nov 21, 2025	Still on market
EL	Nov 21, 2025	Still on market
Spain	Nov 21, 2025	Still on market
Finland	Nov 21, 2025	Still on market
France	Nov 21, 2025	Still on market
Croatia	Nov 21, 2025	Still on market
Hungary	Nov 21, 2025	Still on market
Ireland	Nov 21, 2025	Still on market
Iceland	Nov 21, 2025	Still on market
Italy	Nov 21, 2025	Still on market
Liechtenstein	Nov 21, 2025	Still on market
Lithuania	Nov 21, 2025	Still on market
Luxembourg	Nov 21, 2025	Still on market
Latvia	Nov 21, 2025	Still on market
Malta	Nov 21, 2025	Still on market
Netherlands	Nov 21, 2025	Still on market
Norway	Nov 21, 2025	Still on market
Poland	Nov 21, 2025	Still on market
Portugal	Nov 21, 2025	Still on market
Romania	Nov 21, 2025	Still on market
Sweden	Nov 21, 2025	Still on market
Slovenia	Nov 21, 2025	Still on market
Slovakia	Nov 21, 2025	Still on market
Türkiye	Nov 21, 2025	Still on market
XI	Nov 21, 2025	Still on market

Thermo Scientific X4FR IVD-MD

Thermo Scientific X4FR IVD-MD

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices