Universal 320, 100-127v/50-60hz
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- UNIVERSAL 320, 100-127V/50-60HZ EUDAMEDUNIVERSAL 320 FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- UNIVERSAL 320, 100-127V/50-60HZ EUDAMEDbench-top centrifuge without rotor FDA UDI
- Model / Reference
- 1401-01 EUDAMEDFDA UDI
- Description
- bench-top centrifuge without rotor FDA UDI
Identifiers
- Catalog Number
- 1401-01 FDA UDI
- Primary DI / UDI-DI
- 04050674038393 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050674038393 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 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
Universal 320, 100-127v/50-60hz by Andreas Hettich GmbH — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04050674038393 | 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 (2)
- EUDAMED 7886042f-5f1f-4220-88ce-da423d873c39 61 fields · synced Jun 17, 2026
- FDA UDI 7c120753-66a3-4b46-b289-78d5ea379661 34 fields · synced May 30, 2026