Identity
- Trade Name
- iFuge GC 12 EUDAMED
- Device Name
- Gel Card Centrifuge iFuge GC12 EUDAMED
- Model / Reference
- iFuge GC12 EUDAMEDiFuge GC 12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89080197336554 EUDAMED
- Basic UDI-DI
- 8908019733CLI-CEN-05TR EUDAMED
- Direct Marketing DI
- 89080197336554 EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
New Device
No
EUDAMED
Category: General-purpose centrifuge IVD
iFuge GC 12 by Accumax Lab Devices Private Limited — Class A — IVDR — listed in EUDAMED — 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8908019733CLI-CEN-05TR | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accumax Lab Devices Private Limited
- EUDAMED SRN
- IN-MF-000028076
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 91b473b1-ccf3-4370-a6e4-28372f49baa6 61 fields · synced Jun 19, 2026