Identity
- Trade Name
- Centrifuge, Clinical, Enhanced EUDAMEDGlobe Scientific FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- LOW SPEED CENTRIFUGES EUDAMEDCentrifuge, Clinical, Enhanced Model, 12-Place, 120-240v, 50/60Hz (Includes: 12-Place Rotor for use with: 5mL, 7mL and 10mL Tubes and 8 x 15mL Tubes, Sleeves and Risers) FDA UDI
- Model / Reference
- GCC-E EUDAMEDFDA UDI
- Description
- Centrifuge, Clinical, Enhanced Model, 12-Place, 120-240v, 50/60Hz (Includes: 12-Place Rotor for use with: 5mL, 7mL and 10mL Tubes and 8 x 15mL Tubes, Sleeves and Risers) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840095608381 EUDAMEDFDA UDI
- Basic UDI-DI
- 8721398269LOSPFW EUDAMED
- Direct Marketing DI
- 00840095608381 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Category: General-purpose centrifuge IVD
Centrifuge, Clinical, Enhanced by Globe Scientific Europe B.V. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose centrifuge IVD.
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- 406 — GYROZEN · Class A
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 | 8721398269LOSPFW | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Globe Scientific Europe B.V.
- EUDAMED SRN
- NL-MF-000046521
Sources (2)
- EUDAMED 301dbf11-641d-488c-bbb7-73cf23ac1890 61 fields · synced Jun 18, 2026
- FDA UDI c4e93927-5a12-45d0-a1ed-8f94c0ab0bdc 33 fields · synced May 30, 2026