Hcs

FDA UDI

Class I (US FDA UDI)

by Concordance Healthcare Solutions LLC

Identity

Trade Name: HCS FDA UDI
Generic Name: Mechanical external stethoscope FDA UDI
Device Name: Stainless Steel Stethoscope, Red, Pre-assembled FDA UDI
Model / Reference: HCS8037 FDA UDI
Description: Stainless Steel Stethoscope, Red, Pre-assembled FDA UDI

Identifiers

Primary DI / UDI-DI: 00810132041877 FDA UDI
FDA Product Code: LDE FDA UDI
GMDN Term: Mechanical external stethoscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.1875 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mechanical external stethoscope

Hcs by Concordance Healthcare Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical external stethoscope.

Sklar® — Sklar Corporation · Class I
Adscope® — American Diagnostic Corporation · Class I
Stethoscope — Rashman Corp. · Class I
Greater Goods — Greater Goods, LLC · Class I
Stethoscope — Rashman Corp. · Class I
3M™ Littmann® Classic III™ — 3M COMPANY · Class I
Proscope™ — American Diagnostic Corporation · Class I
Adscope® — American Diagnostic Corporation · Class I

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: Concordance Healthcare Solutions LLC

Sources (1)

FDA UDI b5c541d2-8c0a-4225-9964-5368090b3326 33 fields · synced Jun 8, 2026