Identity
- Trade Name
- Centrifuge, Hematocrit, 24-Place EUDAMEDGlobe Scientific FDA UDI
- Generic Name
- Microhaematocrit centrifuge IVD FDA UDI
- Device Name
- HIGH SPEED CENTRIFUGES NOT COOLED EUDAMEDCentrifuge, Hematocrit, 24-place, 120v, 60Hz, US Plug (includes: 24-Place Hematocrit Rotor Kit with Lid and Reading Disk Lid) FDA UDI
- Model / Reference
- GCH-24 EUDAMEDFDA UDI
- Description
- Centrifuge, Hematocrit, 24-place, 120v, 60Hz, US Plug (includes: 24-Place Hematocrit Rotor Kit with Lid and Reading Disk Lid) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840095608428 EUDAMEDFDA UDI
- Basic UDI-DI
- 8721398269HSNCED EUDAMED
- Direct Marketing DI
- 00840095608428 EUDAMED
- FDA Product Code
- GKG FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- Microhaematocrit centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.6400 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, Hematocrit, 24-Place 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.
- DASH Apex 4 Centrifuge, Fisher — DRUCKER DIAGNOSTICS · Class I
- Allegra X-30, IVD, 100V, 50/60Hz — Beckman Coulter, Inc. · Class A
- LC-04S — Zenith Lab (Jiangsu) Co., Ltd · Class A
- Centrifuge 5920R — Eppendorf SE · Class A
- Thermo Scientific SL1 Plus-MD — Thermo Electron LED GmbH Zweigniederlassung Osterode · Class A
- Medical Centrifuge LX-210L750R — Qingdao Haier Biomedical Technology Co., Ltd. · Class A
- cence — HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO.,LTD. · Class A
- 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 | 8721398269HSNCED | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Globe Scientific Europe B.V.
- EUDAMED SRN
- NL-MF-000046521
Sources (2)
- EUDAMED ab1a69a3-e3c2-4f5c-8d13-d47a1d5c7fad 61 fields · synced Jun 19, 2026
- FDA UDI 2aa427d4-4772-4578-ae1f-bf9c6348ccdb 33 fields · synced May 29, 2026