Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096096

FEI Number

3016096096

Entity Name

COBES INDUSTRIES (BII) COMPANY LIMITED

City/State/Country

Bago Region, MM

Establishment Address

Lot No.62 (Ka),Kwin No.1315,La Hpycr Yoe Kwin,Okkathar(9th) Quarter, Bago township, Bago Region 999091, MM

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COBES INDUSTRIES CO., LTD. (Owner Number: 9088223)

Owner / Operator Contact Address

NO. 39 LIAOYUAN ROAD, XINCHENG DEVELOPMENT ZONE, HEFEI, CN-AH 231600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gemini Bonded Sterilization Wrap Gemini Sterilization Wrap Gemini Sterilization Wrap non-surgical isolation gown Coverall Gemini Bonded Sterilization Wrap Gemini Sterilization Wrap GEMINI STERILZATION WRAP Medline Orbis LVL 3 Surgical Gown MEDLINE STERILIZATION WRAP Gemini Sterilization Wrap SURGICAL DRAPE, Clearview Tear-Away O-Arm Drape coverall

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2017-03-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-03-07
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-17
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-11-15
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-09-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2006-06-07
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2006-06-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

COBES INDUSTRIES CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013960812	COBES INDUSTRIES (BAGO) COMPANY LIMITED	Bago, MM
3013600605	Cobes Industries (Jinzhai) Co., Ltd.	Luan Anhui, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016096096. Last updated year: 2026. Please use registration number 3016096096 when referencing this establishment in official correspondence.