Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013600605

FEI Number

3013600605

Entity Name

Cobes Industries (Jinzhai) Co., Ltd.

City/State/Country

Luan Anhui, CN

Establishment Address

Peasant-worker Pioneer park Baitafan town Jinzhai county, Luan Anhui 237322, CN

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

SURGICAL DRAPE, Clearview Tear-Away O-Arm Drape Medline Orbis LVL 3 Surgical Gown coverall

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2009-08-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-17
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-17
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-09-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-03-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-17
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
3016096096	COBES INDUSTRIES (BII) COMPANY LIMITED	Bago Region, MM

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
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013600605. Last updated year: 2026. Please use registration number 3013600605 when referencing this establishment in official correspondence.