Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007708799

FEI Number

3007708799

Entity Name

CERAMISYS LTD

City/State/Country

Sheffield York, GB

Establishment Address

914 Herries Road, Sheffield York S6 1QW, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ceramisys Ltd (Owner Number: 10029778)

Owner / Operator Contact Address

914 Herries Road, Sheffield, GB-YOR S6 1QW, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103820

PMA Number

N/A

All Registered Proprietary Names

Ceramisys Bioceramic Alumina Implant orbital implant inserter ReproBone¿ Synthetic Resorbable Bone Graft Substitute

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2011-12-26
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2013-04-17
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2011-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Ceramisys Ltd

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
K052493	Steiner Laboratories	SOCKET GRAFT	2006-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2007	Integrated Orbital Implants Inc	2	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

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2242450	KATENA PRODUCTS, INC.	Randolph, NJ, US
3010162973	Synergy Health Marseille SAS	MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007708799. Last updated year: 2026. Please use registration number 3007708799 when referencing this establishment in official correspondence.