Identity
- Trade Name
- Thermo Scientific Fresco 21 EUDAMEDThermo Scientific FDA UDI
- Generic Name
- Microsample centrifuge IVD FDA UDI
- Device Name
- Microliter EUDAMEDFresco 21 230V/50/60Hz FDA UDI
- Model / Reference
- 75002425 EUDAMEDFresco 21 FDA UDI
- Description
- Fresco 21 230V/50/60Hz FDA UDI
Identifiers
- Catalog Number
- 75002425 FDA UDI
- Primary DI / UDI-DI
- 10850685007576 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850685007750024_IVDZR EUDAMED
- Direct Marketing DI
- 10850685007576 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
- GMDN Term
- Microsample 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
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 Fresco 21 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850685007750024_IVDZR | 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 96c1aec0-8cd9-4a3d-9043-15632d941bca 61 fields · synced Jun 19, 2026
- FDA UDI 054c4176-db80-4b21-bb0e-2077278492ec 35 fields · synced May 30, 2026