Identity
- Trade Name
- ROTINA 420 FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- Tabletop centrifuge, refrigerated FDA UDI
- Model / Reference
- ROTINA 420 R - 100V-127V/50-60Hz FDA UDI
- Description
- Tabletop centrifuge, refrigerated FDA UDI
Identifiers
- Catalog Number
- 4706-01 FDA UDI
- Primary DI / UDI-DI
- 04050674035989 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 420 by Andreas Hettich GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 406 — GYROZEN · Class A
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 7a2bbded-bb4d-4242-b581-94eb5690665b 34 fields · synced Jun 8, 2026