Dry Incubator

FDA UDI

Class II (US FDA UDI)

by Astec Co., Ltd.

Identity

Trade Name: Dry Incubator FDA UDI
Generic Name: Assisted reproduction heater/incubator FDA UDI
Model / Reference: EC6S-120MD FDA UDI

Identifiers

Primary DI / UDI-DI: 04580647510026 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

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

Dry Incubator by Astec Co., 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: Astec Co., Ltd.

Sources (1)

FDA UDI 468941dd-38db-4b7e-af57-385b6d57ce94 32 fields · synced May 30, 2026