Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614107

FEI Number

3002867000

Entity Name

ALTOMED LTD.

City/State/Country

Boldon Colliery South Tyneside, GB

Establishment Address

14 Burford Way, Boldon Colliery South Tyneside NE35 9PZ, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

ALTOMED LTD. (Owner Number: 9043181)

Owner / Operator Contact Address

14 Burford Way, BOLDON BUSINESS, PARK,, BOLDON, TYNE & WEAR, GB-NOTA NE35 9PZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Altomed Malhotra Endonasal DCR Nibbler Delicate Altomed Traquair Periosteal Elevator Altomed Altomed Altomed Altomed Altomed Altomed Altomed Altomed Altomed Altomed Malhotra Platinum Segments Altomed Altomed Altomed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXB	Probe	Orthopedic	Class 1	888.4540	2000-10-03
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2018-06-22
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2000-10-03
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-06-22
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2000-10-03
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2000-10-03
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-03
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-03
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2000-10-03
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-03
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-03
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-03
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-03
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2017-10-31
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-03
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2000-10-03
HPB	Clip, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1410	2000-10-03

Official Correspondent

No official correspondent registered.

US Agent Details

Sylvia Lemke Business: Microsurgical Technology Email: slemke@microsurgical.com Phone: (888) 2793323

Related Public Records

Same Entity

ALTOMED 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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

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3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3015516266	Depuy Ireland UC	Co. Cork Munster, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614107. Last updated year: 2026. Please use registration number 9614107 when referencing this establishment in official correspondence.