Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610102

FEI Number

3002807786

Entity Name

AIDIAN OY

City/State/Country

ESPOO Uusimaa, FI

Establishment Address

KOIVU-MANKKAAN TIE 6B, ESPOO Uusimaa 02200, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AIDIAN OY (Owner Number: 9062384)

Owner / Operator Contact Address

Koivu-Mankkaan tie 6 B, --, Espoo, FI-NOTA 02200, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043125

PMA Number

N/A

All Registered Proprietary Names

Uricult CLED/EMB Uricult CLED/MacConkey UniQ PINP RIA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2007-11-09
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2005-12-14

Official Correspondent

Rina Wahlroos

US Agent Details

Kim Young-A Business: Princeton BioMeditech Corporation Email: yakim@pbmc.com Phone: (732) 2741000

Related Public Records

Same Entity

AIDIAN OY

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-0040-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
Z-0041-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Z-0044-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.

Similar Registrations

Registration Number	Establishment Name	Location
9615754	BIOMERIEUX SA	LA BALME LES GROTTES Isere, FR
2022807	HARDY DIAGNOSTICS	Orcutt, CA, US
8023060	BIO-RAD	STEENVOORDE Nord, FR
9680687	CHROMAGAR	Saint-Denis Seine-Saint-Denis, FR
1111096	BECTON, DICKINSON & CO.	Cockeysville, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610102. Last updated year: 2026. Please use registration number 9610102 when referencing this establishment in official correspondence.