Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043049733

FEI Number

3043049733

Entity Name

OPERATING THEATRE MEDICAL BANGLADESH COMPANY LIMITED

City/State/Country

Kaliakair Gazipur, BD

Establishment Address

146, Baganbari, Lashkarchala, Haturiyachala, Kaliakair Gazipur 1751, BD

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

OPERATING THEATRE MEDICAL BANGLADESH COMPANY LIMITED (Owner Number: 10094814)

Owner / Operator Contact Address

146, Baganbari, Lashkarchala, Haturiyachala, Kaliakair, BD-18 1751, BD

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bouffant Cap, Surgeon Cap Apron, Lab Coat, Scrub Top, Scrub Pants, Surgeon Jacket, Shorts Boot Cover, Shoe Cover Examination Gown, Patient Gown Scrub Suit, Scrub Wear, Surgical Suit Bed Sheet, Pillow Case, Bed Cover, Blanket Surgical Dress

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-12-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-12-25
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2025-12-25
FME	Gown, Examination	General Hospital	Class 1	880.6265	2025-12-25
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-12-25
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-12-25
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-12-25

Official Correspondent

LIU QIAN

US Agent Details

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

Related Public Records

Same Entity

OPERATING THEATRE MEDICAL BANGLADESH COMPANY LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043049733. Last updated year: 2026. Please use registration number 3043049733 when referencing this establishment in official correspondence.