Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003617485

FEI Number

3003617485

Entity Name

Ionisos Baltics OU

City/State/Country

Saue vald Harjumaa, EE

Establishment Address

Kurvi tee 406a, Alliku, Saue vald Harjumaa 76403, EE

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

EPIONE BIDCO (Owner Number: 10042490)

Owner / Operator Contact Address

415 allee de Frenes, bat Squale, LIMONEST, FR-69 69760, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iCare TP022 Probes iCare TP01s Probes iCare TP01s Probes LiDCOunity v2 Hemodynamic Monitoring System LIDCOunity v2 Femoral Epidrill Patellar Epidrill iCare TP01s Probes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2024-06-05
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2025-01-23
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2025-01-23
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2024-04-16
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2025-01-23
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2019-12-05
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2019-12-05
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2025-02-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-12-04
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2023-03-16
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2017-11-30
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2017-11-30
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2020-01-17
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2021-01-05

Official Correspondent

Alexandra Basset

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

EPIONE BIDCO

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010191069	IONISOS	Tarancon Cuenca, ES
3003775072	IONISOS	CHAUMESNIL Grand Est, FR
3010329663	IONISOS Pouzauges	Pouzauges Vendee, FR
3002807295	IONISOS	SABLE-SUR-SARTHE, FR
3010178296	IONISOS	Dagneux Ain, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K870750	Keeler Instruments, Inc.	KEELER PULSAIR NON CONTACT TONOMETER	1987-03-17
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
1319721	REICHERT INC.	DEPEW, NY, US
3004681519	Sterigenics Belgium Fleurus SA	Fleurus Hainaut, BE
1000391004	KEELER LTD.	WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
3010610157	CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD	Chongqing, CN
3006550126	SPEEDWAY	India Delhi, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003617485. Last updated year: 2026. Please use registration number 3003617485 when referencing this establishment in official correspondence.