Identity
- Trade Name
- Thermo Scientific Cryofuge 8 EUDAMEDThermo Scientific FDA UDI
- Generic Name
- Blood bank centrifuge FDA UDI
- Device Name
- Polaris MD EUDAMEDCryofuge 8, 380, 400, 417V 50/60 Hz FDA UDI
- Model / Reference
- 75008603 EUDAMEDThermo Scientific Cryofuge 8 FDA UDI
- Description
- Cryofuge 8, 380, 400, 417V 50/60 Hz FDA UDI
Identifiers
- Catalog Number
- 75008603 FDA UDI
- Primary DI / UDI-DI
- 10850033408918 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850685007750076_MDQH EUDAMED
- Direct Marketing DI
- 10850033408918 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 EUDAMEDClass 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 Cryofuge 8 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850685007750076_MDQH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Thermo Electron LED GmbH Zweigniederlassung Osterode
- EUDAMED SRN
- DE-MF-000008786
Sources (2)
- EUDAMED d4b0e11e-cfbb-425d-a440-42ebcb930f3e 61 fields · synced Jul 12, 2026
- FDA UDI cd945363-bbc8-4d48-abe9-99e3176adcab 35 fields · synced May 30, 2026