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Thermo Scientific Sorvall BP 16 Heavy Duty

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 75007682

by Thermo Electron LED GmbH Zweigniederlassung Osterode

Identity

Trade Name
Thermo Scientific Sorvall BP 16 Heavy Duty EUDAMED
Thermo Scientific FDA UDI
Generic Name
Blood bank centrifuge FDA UDI
Device Name
Polaris MD EUDAMED
Sorvall BP 16 HD, 200-240 V, 50/60Hz FDA UDI
Model / Reference
75007682 EUDAMED
Sorvall BP 16 Heavy duty FDA UDI
Description
Sorvall BP 16 HD, 200-240 V, 50/60Hz FDA UDI

Identifiers

Catalog Number
75007682 FDA UDI
Primary DI / UDI-DI
10850685007415 EUDAMEDFDA UDI
Basic UDI-DI
0850685007750076_MDQH EUDAMED
Direct Marketing DI
10850685007415 EUDAMED
FDA Product Code
KSO FDA UDI
EMDN Code
B99 HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER EUDAMED
GMDN Term
Blood bank centrifuge FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
864.9275 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

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

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 BP 16 Heavy Duty by Thermo Electron LED GmbH Zweigniederlassung Osterode — Class IIa — MDR, 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/MDR

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 1163dd27-5d8c-450d-a449-e67307b1087d 61 fields · synced Jun 18, 2026
  • FDA UDI f59c71e7-eacc-4e25-a442-b43e668f7175 35 fields · synced May 30, 2026