DSM Biomedical Centrifuge

FDA UDI

Class II (US FDA UDI)

by Dsm Biomedical, Inc.

Identity

Trade Name: DSM Biomedical Centrifuge FDA UDI
Generic Name: Haematological concentrate system centrifuge FDA UDI
Device Name: Centrifuge for preparation of platelet rich plasma FDA UDI
Model / Reference: 64002-08 FDA UDI
Description: Centrifuge for preparation of platelet rich plasma FDA UDI

Identifiers

Primary DI / UDI-DI: M263640020808 FDA UDI
FDA Product Code: ORG FDA UDI
GMDN Term: Haematological concentrate system centrifuge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9245 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Haematological concentrate system centrifuge

DSM Biomedical Centrifuge by Dsm Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematological concentrate system centrifuge.

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Autologous Platelet Separator — Arteriocyte Medical Systems, Inc. · Class I
3CP™ Centrifuge Kit — Reapplix ApS · Class I
Autologous Platelet Separator — Arteriocyte Medical Systems, Inc. · Class I
LT Medical Centrifuge for PRP — Zhuhai Longtime Biological Technology Co., Ltd · Class I
3CP™ Centrifuge — Reapplix ApS · Class I
LT Medical Centrifuge for PRP — Zhuhai Longtime Biological Technology Co., Ltd · Class I
PEAK® Platelet Rich Plasma System — DSM BIOMEDICAL, INC. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Dsm Biomedical, Inc.

Sources (1)

FDA UDI ee86fed0-c922-4da4-9fe1-e140ee859c28 33 fields · synced Jun 8, 2026