Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006234591

FEI Number

3006234591

Entity Name

SDI SURGICAL DEVICE INTERNATIONAL GMBH

City/State/Country

Bruegg Bern, CH

Establishment Address

Mattenstrasse 11, Bruegg Bern 2555, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SDI SURGICAL DEVICE INTERNATIONAL GMBH (Owner Number: 9096119)

Owner / Operator Contact Address

1 Helmstrasse, --, Port, CH-NOTA 2562, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scleral marker Toric Katena Katena Katena Katena

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2009-04-30
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-07-22
HLF	Device, Measuring, Lens Radius, Ophthalmic	Ophthalmic	Class 1	886.1430	2025-07-22
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-05-26

Official Correspondent

MEYER THOMAS

US Agent Details

Stacie Kirsch Business: Diatome US Email: info@diatomeknives.com Phone: (215) 4128390

Related Public Records

Same Entity

SDI SURGICAL DEVICE INTERNATIONAL GMBH

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
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-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006234591. Last updated year: 2026. Please use registration number 3006234591 when referencing this establishment in official correspondence.