K-Systems

FDA UDI

Class II (US FDA UDI)

by Research Instruments , Ltd.

Identity

Trade Name: K-Systems FDA UDI
Generic Name: Assisted reproduction heater/incubator FDA UDI
Device Name: Assisted Reproduction Accessories FDA UDI
Model / Reference: G210 InviCell US Incubator FDA UDI
Description: Assisted Reproduction Accessories FDA UDI

Identifiers

Catalog Number: K61500 FDA UDI
Primary DI / UDI-DI: 05060554120307 FDA UDI
FDA Product Code: PUB FDA UDI
GMDN Term: Assisted reproduction heater/incubator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6120 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assisted reproduction heater/incubator

K-Systems by Research Instruments , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Research Instruments , Ltd.

Sources (1)

FDA UDI 49ce8761-7eac-4ec0-980e-6bd8e82c2a79 36 fields · synced Jun 1, 2026