Hopkins

FDA UDI

Class II (US FDA UDI)

by American Diagnostic Corporation

Identity

Trade Name: Hopkins FDA UDI
Generic Name: Aneroid manual sphygmomanometer FDA UDI
Device Name: Pocket Aneroid Sphyg,Newborn, Black, HOP PL FDA UDI
Model / Reference: 760NHOP FDA UDI
Description: Pocket Aneroid Sphyg,Newborn, Black, HOP PL FDA UDI

Identifiers

Catalog Number: 760NHOP FDA UDI
Primary DI / UDI-DI: 00634782032197 FDA UDI
FDA Product Code: DXQ FDA UDI
GMDN Term: Aneroid manual sphygmomanometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Aneroid manual sphygmomanometer

The Hopkins device, a portable and user-friendly blood pressure cuff for newborns, allows parents to accurately measure their child's blood pressure with ease. Made with precision and comfort in mind, this medical device features an inflatable cuff that fits snugly around the limb, a reliable inflation bulb for controlled air pressure, and a clear indication needle that rotates on a calibrated scale. With its simple design and gentle touch, the Hopkins device is perfect for newborns who require regular blood pressure checks during their first year of life.

Similar devices

Also classified as Aneroid manual sphygmomanometer.

e-mega® black, disinfectable one-piece cuff, small adult size 2-tube — Rudolf Riester GmbH & Co. KG · Class II
BAUM — W.A. BAUM CO., INC. · Class II
Amico Diagnostic Station — Amico Diagnostic Incorporated · Class II
MDF® — MDF Instruments Medifriend Inc. · Class II
DIXIEEMS — Wenzhou Caretek Medical Device Co., Ltd. · Class II
Hopkins Medical Products® — HOPKINS UNIFORM COMPANY · Class II
HEINE GAMMA® GP — Heine Optotechnik GmbH & Co. KG · Class II
Aneroids (82 etc.) — Rashman Corp. · Class II

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: American Diagnostic Corporation

Sources (1)

FDA UDI 06ce32dd-d33c-4437-947b-6b57b31ecf9e 37 fields · synced Jul 16, 2026