Atellica Sample Handler Additional

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Atellica Sample Handler Additional FDA UDI
Generic Name: Specimen processing instrument IVD FDA UDI
Device Name: Atellica SAMPLE HANDLER ADDITIONAL MODULE FDA UDI
Model / Reference: 11069004 FDA UDI
Description: Atellica SAMPLE HANDLER ADDITIONAL MODULE FDA UDI

Identifiers

Catalog Number: 11069004 FDA UDI
Primary DI / UDI-DI: 00630414002460 FDA UDI
510(k) Number: K161954 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Specimen processing instrument IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Specimen processing instrument IVD

Atellica Sample Handler Additional by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161954 also covers:

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: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 627d346f-aec5-4717-857e-b6d0fd2b173b 36 fields · synced May 30, 2026