Eba 200 - 100v-127v/50-60hz
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- EBA 200 - 100V-127V/50-60HZ EUDAMEDEBA 200 FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- EBA 200 - 100V-127V/50-60HZ EUDAMEDEBA 200 / EBA 200 S EUDAMEDTabletop centrifuge FDA UDI
- Model / Reference
- 1800-01 EUDAMED1800, 1802 EUDAMEDEBA 200 - 100V-127V/50-60Hz FDA UDI
- Description
- Tabletop centrifuge FDA UDI
Identifiers
- Catalog Number
- 1801-01 FDA UDI
- Primary DI / UDI-DI
- 04050674077804 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050674077804 EUDAMED040506740100069U EUDAMED
- Direct Marketing DI
- 04050674077804 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose centrifuge IVD
Eba 200 - 100v-127v/50-60hz by Andreas Hettich GmbH — Class IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-04050674077804 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04050674077804 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (3)
- EUDAMED 3a1c1e81-19be-4da6-8966-5484a55111e4 61 fields · synced Jul 22, 2026
- FDA UDI 171c6706-97c4-4791-b649-f41ad243c776 34 fields · synced May 30, 2026
- EUDAMED 887a37ca-264b-421d-80aa-3fb03a40b209 61 fields · synced Jul 22, 2026