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Universal 320 R
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1406-01Model 1401, 1406
Identity
- Trade Name
- UNIVERSAL 320 R, 115-127V 60Hz EUDAMEDUNIVERSAL 320 R FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- UNIVERSAL 320 / 320 R EUDAMEDrefrigerated bench-top centrifuge without rotor FDA UDI
- Model / Reference
- 1406-01 EUDAMEDFDA UDI1401, 1406 EUDAMED
- Description
- refrigerated bench-top centrifuge without rotor FDA UDI
Identifiers
- Catalog Number
- 1406-01 FDA UDI
- Primary DI / UDI-DI
- 04050674038263 EUDAMEDFDA UDI
- Basic UDI-DI
- 040506740100139R EUDAMED
- Direct Marketing DI
- 04050674038263 EUDAMED
- FDA Product Code
- GKG FDA UDI
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.6400 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
Universal 320 R by Andreas Hettich GmbH & Co. KG — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH & Co. KG
Sources (2)
- FDA UDI 7960882e-4277-4bae-8b68-5c322a1bf472 34 fields · synced Jun 18, 2026
- EUDAMED 88d779fc-60c2-402e-a1a0-e5bfe01eb864 61 fields · synced Jun 18, 2026