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Fiscal Year 2020 Certification of Registration

This document certifies that Changchun Wancheng Bio-Electron Co., Ltd has completed FDA establishment registration and device listing as a manufacturer and exporter through December 31, 2020. It includes a list of 19 device listing numbers covering products such as urine test strips, water test kits, COVID-19 test kits, and protective masks. The certificate holder's registration and ability to export medical devices to the US is verified until the expiration date.

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miguel
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187 views2 pages

Fiscal Year 2020 Certification of Registration

This document certifies that Changchun Wancheng Bio-Electron Co., Ltd has completed FDA establishment registration and device listing as a manufacturer and exporter through December 31, 2020. It includes a list of 19 device listing numbers covering products such as urine test strips, water test kits, COVID-19 test kits, and protective masks. The certificate holder's registration and ability to export medical devices to the US is verified until the expiration date.

Uploaded by

miguel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Fiscal Year 2020

CERTIFICATION OF REGISTRATION
This certifies that:
CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD
Floor 5, Building 4, No. 388, Huoju Road, High-Tech Development Zone Changchun, Jilin,
130012, CHINA

has completed the FDA Establishment Registration (as manufacturer and foreign
exporter) and Device Listing with the US Food & Drug Administration, through
The Owner/ Operator Number for this Registration is :10049606

Device Listing #:
See the attachment for the devicelisting No.

ABmed will confirm that such registration remains effective upon request and
presentation of this certificate until the end of the year stated above, unless said
registration is terminated after issuance of this certificate. ABmed makes no other
representations or warranties, nor does this certificate make any representations or
warranties to any person or entity other than the named certificate holder, for
whose sole benefit it is issued. This certificate does not denote endorsement or
approval of the certificate‐holder’s device or establishment by the U.S Food and
Drug Administration.
ABmed assumes no liability to any person or entity in connection with foregoing.

Date of verification: Dec 19, 2019


Date of expiration: Dec 31, 2020

SH OFFICE
TEL:0086-21-50313932 Boyle Wang Phone:0086-18930777676 info@truthful.com.cn
ABMED SERVICE INC.
36 South 18th Avenue, Suite A Brighton,CO USA 80601
TEL:213-375-3998 FAX:213-375-3998 info@abmed.com.cn
.

Listing No Code Device Name


D245090 CDM DIAZONIUM COLORIMETRY,
UROBILINOGEN (URINARY, NON-QUANT.)
D245091 CEN Dye-indicator, pH (urinary, non-quantitative)
D318333 KSL SOLUTION, COPPER SULFATE FOR
SPECIFIC GRAVITY DETERMINATIONS
D313367 LXG EQUIPMENT, LABORATORY, GENERAL
PURPOSE, LABELED OR PROMOTED
FOR A SPECIFIC MEDICAL USE
D313368 HMT Drape, patient, ophthalmic
D245784 JRE REFRACTOMETER FOR CLINICAL USE
D309523 IGD SOLUTION, FORMOL CALCIUM
D309522 JLA CONVERSION TO CREATININE,CREATINE
D245092 JIN NITROPRUSSIDE, KETONES (URINARY,
NON-QUANT.)
D245093 JIR INDICATOR METHOD, PROTEIN OR
ALBUMIN (URINARY, NON-QUANT.)
D245094 JJB AZO-DYES, COLORIMETRIC, BILIRUBIN
& ITS CONJUGATES (URINARY, NON-QUANT.)
D245095 JMA ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE
(SPECTROPHOTOMETRIC)
D245096 JMT DIAZO (COLORIMETRIC), NITRITE (URINARY,
NON-QUANT)
D245097 LJX TEST, URINE LEUKOCYTE
D245098 KQO AUTOMATED URINALYSIS SYSTEM
D313367 LXG WATER TEST KITS,REAGENT STRIPS FOR
WATER,WATER TEST PAPER
D391126 QKO The COVID-2019 ANTIGEN RAPID TEST KIT
The COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT
D391130 QKR Disposable Protective Mask

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