XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Xiamen Fujian, CN · Registration 3016680688

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016680688
FEI Number
3016680688
Entity Name
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD
City/State/Country
Xiamen Fujian, CN
Establishment Address
No. 1 & No.3 Building, No.6, Ji'an Road, Tong'an District, Xiamen Fujian 361100, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD (Owner Number: 10062942)
Owner / Operator Contact Address
No.1 & No.3 Building, No.6, Jia'n Road, Tong'an District, Xiamen, CN-FJ 361100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Bed Sheet Disposable Surgical Gowns (S, M, L, XL, XXL, XXXL) Disposable Surgical Mask Disposable Isolation Gowns (S, M, L, XL, XXL, XXXL) Surgical Gown Disposable Isolation Gowns (S, M, L, XL, XXL, XXXL) Adult Nursing Pad, Baby Care Mat, Adult Diapers, Baby Diapers, Adult Insert Diapers Caps Isolation Gown Face Mask

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2020-03-13
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2023-12-14
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2021-11-03
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2023-12-14
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2020-03-13
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2023-12-14
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2020-03-13
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2020-03-13
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-13
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2020-03-13

Official Correspondent

Jianli Kang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09

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3012047128 ATHFAR 828, Inc. Big Rapids, MI, US
3014666579 SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD. Zaozhuang Shandong, CN
3007663056 SHANGHAI HUIHU MEDICAL APPLIANCE CO. LTD. Shanghai, CN
3015068387 GEORGE COUREY INC Montreal Quebec, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016680688. Last updated year: 2026. Please use registration number 3016680688 when referencing this establishment in official correspondence.
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