Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010372554

FEI Number

3010372554

Entity Name

CLINICAL POLYMER TECHNOLOGIES LTD

City/State/Country

Coalville Leicestershire, GB

Establishment Address

Unit 3 Garden Court, Gee Road, Whitwick Business Park,, Coalville Leicestershire LE67 4NB, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Clinical Polymer Technologies Ltd (Owner Number: 10043601)

Owner / Operator Contact Address

Unit 3 Garden Court, Gee Road, Whitwick Business Park,, Coalville, GB-LEC LE67 4NB, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medicina Ltd OXFORD Medicina Ltd Versius Plus Osteotec Silicone Finger Sizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2023-09-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-03-04
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2016-02-02
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2023-09-12
SCV	Modular Electromechanical Surgical System	General, Plastic Surgery	Class 2	878.4964	2026-02-05
HWT	Template	Orthopedic	Class 1	888.4800	2024-10-29
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2020-12-15

Official Correspondent

Garry Shaw

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Clinical Polymer Technologies Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3015300984	INNOVATION LABS, INC	Mahwah, NJ, US
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
3002807315	SYNERGY HEALTH STERILISATION UK LTD	Daventry Northamptonshire, GB
3037918935	Pharmamed SA.	Anderlecht Brussels-Capital Region, BE
3014195785	CLINISUPPLIES (NANJING) CO., LTD	Nanjing Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010372554. Last updated year: 2026. Please use registration number 3010372554 when referencing this establishment in official correspondence.