← Back to catalogue

Roto Silenta 630 Rs

FDA UDI

Class I (US FDA UDI)

by Andreas Hettich GmbH & Co. KG

Identity

Trade Name
ROTO SILENTA 630 RS FDA UDI
Generic Name
Blood bank centrifuge FDA UDI
Device Name
Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate, nitrogen purging FDA UDI
Model / Reference
ROTO SILENTA 630 RS, Solekühlung FDA UDI
Description
Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate, nitrogen purging FDA UDI

Identifiers

Catalog Number
5005-60 FDA UDI
Primary DI / UDI-DI
04050674031134 FDA UDI
FDA Product Code
JQC FDA UDI
GMDN Term
Blood bank centrifuge 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: Blood bank centrifuge

Roto Silenta 630 Rs by Andreas Hettich GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood bank centrifuge.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Andreas Hettich GmbH & Co. KG

Sources (1)

  • FDA UDI 9a9ef4ec-48d7-4472-ac17-9b173bdabe06 34 fields · synced Jun 7, 2026