Innokas Medical Estonia Ou

FDA Device Registration & Listing · Tallinn Harjumaa, EE · Registration 3010399798

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010399798
FEI Number
3010399798
Entity Name
Innokas Medical Estonia Ou
City/State/Country
Tallinn Harjumaa, EE
Establishment Address
Paneeli 2, Tallinn Harjumaa 13816, EE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Innokas Yhtyma Oy (Owner Number: 10026175)
Owner / Operator Contact Address
Vihikari 10, KEMPELE, FI-14 90440, FI
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

QuikRead go Instrument Icare ic200 tonometer OFC100L, Oivi Fundus Camera Nox A1s Recorder Coala Heart Monitor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2016-06-01
HKY Tonometer, Manual Ophthalmic Class 2 886.1930 2020-01-17
PJZ Camera, Ophthalmic, General-Use Ophthalmic Class 2 886.1120 2025-09-29
KZM Device, Muscle Monitoring Physical Medicine Class 2 890.1375 2025-02-13
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2025-02-13
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2019-08-13

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

Innokas Yhtyma Oy
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007615597 INNOKAS MEDICAL OY KEMPELE Pohjois-Pohjanmaa, FI

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K760232 Instrumentation Laboratory CO PRINTER, IL 460 1976-08-26
K820986 Dart Medical Equipment EKG MONITORS, VARIOUS MODELS 1982-04-29
K910450 Medtech Industries, Inc. CARD GUARD-3000 ECG TELEPHONE ADAPTER 1991-05-07
K761318 Cambridge Instruments, Inc. 3038 OPTION B-COMPUT. TRANS. TERMINAL 1977-01-06
K972649 Reynolds Medical , Ltd. CARDIOCALL CARDIAC EVENT RECORDER 1997-12-04

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9610806 Siemens Healthcare Diagnostics Products GmbH MARBURG Hesse, DE
1000312377 Derungs Licht AG Gossau Sankt Gallen, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010399798. Last updated year: 2026. Please use registration number 3010399798 when referencing this establishment in official correspondence.
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