Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008348697

FEI Number

3008348697

Entity Name

Wild GmbH

City/State/Country

Voelkermarkt Karnten, AT

Establishment Address

Wildstrasse 4, Voelkermarkt Karnten 9100, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WILD GmbH (Owner Number: 10032507)

Owner / Operator Contact Address

Wildstrasse 4, Voelkermarkt, AT-2 9100, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Spectralis Anterior Segment Module SPECTRALIS with Flex Module SPECTRALIS HRA + OCT and variants SPECTRALIS HRA+OCT and variants

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2013-01-29
MYC	Ophthalmoscope, Laser, Scanning	Ophthalmic	Class 2	886.1570	2013-01-29
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2024-11-21
MYC	Ophthalmoscope, Laser, Scanning	Ophthalmic	Class 2	886.1570	2024-11-21
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2024-11-21
MYC	Ophthalmoscope, Laser, Scanning	Ophthalmic	Class 2	886.1570	2024-11-21
MYC	Ophthalmoscope, Laser, Scanning	Ophthalmic	Class 2	886.1570	2023-11-20
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2023-11-20

Official Correspondent

Christian Rabitsch

US Agent Details

Lena Sattler Business: Orasi Consulting Email: lena@orasiconsulting.com Phone: (440) 5543706

Related Public Records

Same Entity

WILD GmbH

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-0024-2013	Optovue Inc.	2	Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

Similar Registrations

Registration Number	Establishment Name	Location
3008729548	Topcon Yamagata Co., LTD	Yamagata-KEN, JP
3010000450	CRYSTALVUE MEDICAL CORPORATION	Taoyuan Dist.,, TW
9614661	TOPCON CORP.	TOKYO, JP
3006809695	Leica Microsystems NC, Inc.	Durham, NC, US
9616199	HUVITZ CO., LTD.	Anyang-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008348697. Last updated year: 2026. Please use registration number 3008348697 when referencing this establishment in official correspondence.