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Starrsed

FDA UDI

Class I (US FDA UDI)

by Mechatronics Usa

Identity

Trade Name
Starrsed FDA UDI
Generic Name
Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Device Name
Automated analyzer for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) for human blood samples in conformity with the Westergren standard. FDA UDI
Model / Reference
A0030112 FDA UDI
Description
Automated analyzer for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) for human blood samples in conformity with the Westergren standard. FDA UDI

Identifiers

Primary DI / UDI-DI
08719189137781 FDA UDI
FDA Product Code
GKB FDA UDI
GMDN Term
Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

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
Sterilization Method
Liquid Chemical FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Erthrocyte sedimentation rate (ESR) analyser IVD

Starrsed by Mechatronics Usa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Erthrocyte sedimentation rate (ESR) analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mechatronics Usa

Sources (1)

  • FDA UDI 5311d3b6-b139-4c2b-bf95-d417c851907a 34 fields · synced May 30, 2026