Hemoglobin Meter

2 catalogue numbers from PH-01A,1 Set/box, listed by Urit Medical Electronic Co., Ltd., China, under Control, Hemoglobin. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GGM
Manufacturer City Province Registered as Device types
Acon Biotech (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29
Urit Medical Electronic Co., Ltd. Guilin Guangxi Contract manufacturer 28

Record

Regulatory record for Hemoglobin Meter
Listed by Urit Medical Electronic Co., Ltd., China
FDA product code GGM
Device type Control, Hemoglobin
Device class Class 2
Regulation 21 CFR 864.8625
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2026-06-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment temperature -20 to 55 °C

Catalogue Numbers

Catalogue numbers for Hemoglobin Meter
Catalogue number Size Status
PH-01A,1 Set/box In distribution
PH-01,1 Set/box In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Eurotrol Eurotrol B.V. 11
CueSee® Co-OX Eurotrol B.V. 11
Research and Diagnostic Systems Research AND Diagnostic Systems, Inc. 10
Liquichek Bio-Rad Laboratories Inc. 8
InteliQ Bio-Rad Laboratories Inc. 4
Hemoglobin Test Strip Urit Medical Electronic Co., Ltd. 3
HemoTrol Duo Eurotrol B.V. 3
Lyphochek Bio-Rad Laboratories Inc. 3
McKesson Mckesson Medical-Surgical Inc. 3
HemoTrol WB Eurotrol B.V. 3
Hemoglobin Control Solution Urit Medical Electronic Co., Ltd. 3
Henry Schein Henry Schein, Inc. 1

Showing 12 of 25. All products under Control, Hemoglobin

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer