Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015633688

FEI Number

3015633688

Entity Name

NULINE MEDICAL

City/State/Country

Patna South Ayrshire, GB

Establishment Address

Nuline Medical Limited, Doonview, Patna South Ayrshire KA6 7JW, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nuline Limited (Owner Number: 10061624)

Owner / Operator Contact Address

Nuline Limited, Doonview, Patna, GB-EAY KA6 7JW, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

wrap for sterilisation Surgical drape Surgical accessory Surgical Gown Surgical mask Ophthalmic patient drape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2019-11-06
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-11-06
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-07-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-06
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-08
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2019-11-06

Official Correspondent

Suzanne Slater

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Nuline Limited

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015633688. Last updated year: 2026. Please use registration number 3015633688 when referencing this establishment in official correspondence.