Astopad®

FDA UDI

Class II (US FDA UDI)

by Stihler Electronic GmbH

Identity

Trade Name: ASTOPAD® FDA UDI
Generic Name: Electric pad whole-body heating system FDA UDI
Device Name: COV070-NA FDA UDI
Model / Reference: COV070-NA FDA UDI
Description: COV070-NA FDA UDI

Identifiers

Catalog Number: COV070-NA FDA UDI
Primary DI / UDI-DI: 04260114140221 FDA UDI
510(k) Number: K202197 FDA UDI
FDA Product Code: DWJ FDA UDI
GMDN Term: Electric pad whole-body heating system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5900 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

MRI Safety

MR Unsafe FDA UDI

Category: Electric pad whole-body heating system

Astopad® by Stihler Electronic GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K202197 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 II	Pending data

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Manufacturer

Manufacturer: Stihler Electronic GmbH

Sources (1)

FDA UDI 493bbe10-bf59-4561-8485-abdebba5a675 35 fields · synced May 30, 2026