Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015651306

FEI Number

3015651306

Entity Name

Domel, d.o.o., (Business Unit LABS)

City/State/Country

Zelezniki, SI

Establishment Address

Otoki 21, Zelezniki 4228, SI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Domel, d.o.o., (Business Unit LABS) (Owner Number: 10091982)

Owner / Operator Contact Address

Otoki 21, Zelezniki, SI-146 4228, SI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COOL INCUBATOR 56 120V COOL TOWER 23 120V WATER BATH 6 120V COOL INCUBATOR 23 120V INCUBATOR 23 120V INCUBATOR 10 120V INCUBATOR 10 Analog 120V INCUBATOR 56 120V CENTRIC MF 48 120V CENTRIC CF 48 120V CENTRIC CF 220 120V CENTRIC 250 IVD 120V CENTRIC 260 R 120V CENTRIC CF 108 GR 120V CENTRIC MF 220 IVD 120V CENTRIC MF 48 R IVD 120V CENTRIC MF 48 IVD 120V CENTRIC CF 220 IVD 120V CENTRIC CF 48 R 120V CENTRIC 260 120V CENTRIC 400 R 120V CENTRIC CF 108 R 120V CENTRIC 250 120V CENTRIC MF 48 R 120V CENTRIC 350 IVD 120V CENTRIC MF 220 120V CENTRIC 350 120V

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2024-11-22
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2024-11-22

Official Correspondent

ANDREJ ERZEN

US Agent Details

CODY WHITE Business: SCIENTIFIC CALIBRATION, INC. Email: ckwhite@scical.com Phone: (866) 7242252

Related Public Records

Same Entity

Domel, d.o.o., (Business Unit LABS)

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015651306. Last updated year: 2026. Please use registration number 3015651306 when referencing this establishment in official correspondence.