Identity
- Trade Name
- ROTINA 380, 100-127V 50-60Hz EUDAMEDROTINA 380 FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- ROTINA 380 / 380 R EUDAMEDTabletop centrifuge FDA UDI
- Model / Reference
- 1701, 1706 EUDAMED1701-01 EUDAMEDROTINA 380 - 100V-127V/50-60Hz FDA UDI
- Description
- Tabletop centrifuge FDA UDI
Identifiers
- Catalog Number
- 1701-01 FDA UDI
- Primary DI / UDI-DI
- 04050674037495 EUDAMEDFDA UDI
- Basic UDI-DI
- 040506740100149T EUDAMED
- Direct Marketing DI
- 04050674037495 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
- 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
Yes
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
Category: General-purpose centrifuge IVD
Rotina 380 by Andreas Hettich GmbH & Co. KG — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH & Co. KG
Sources (2)
- FDA UDI 62efa45c-a16a-4c7e-88f7-2acb97c8aebb 34 fields · synced Jul 14, 2026
- EUDAMED 88d4944e-84b3-40a7-a82e-a8df0ba5809a 61 fields · synced Jul 14, 2026