Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019916040

FEI Number

3019916040

Entity Name

NUVE SANAYI MALZEMELERI IMALAT VE TICARET A.S.

City/State/Country

ANKARA, TR

Establishment Address

Saracalar Mah. Saracalar Kumeevleri No: 4/2 Akyurt 06750 ANKARA, ANKARA 06750, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NUVE Sanayi Malzemeleri Imalat ve Ticaret A.S. (Owner Number: 10082452)

Owner / Operator Contact Address

Saracalar Mah. Saracalar Kumeevleri No: 4/2 Akyurt 06750 ANKARA, ANKARA, TR-06 06750, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KN 120 BLOOD BANK REFRIGERATOR ND 4/12 & NS 103 WATER DISTILLERS FR 290 / FR 490 DF 290/ DF 490/ DF 590 MD 120 MEDICAL REFRIGERATOR MR 120 LABORATORY REFRIGERATOR ES 120 / 252 COOLING INCUBATORS MN 090 / 120 CLASS II MICROBIOLOGICAL SAFETY CABINETS LH SERIES HORIZONTAL LAMINAR AIR FLOW CABINETS LN 120 LAMINAR AIR FLOW CABINETS CS 120 CLASS II MICROBIOLOGICAL SAFETY CABINETS (MOTORIZED WINDOW) FN 400P / 500P & KD 200 / 400 & MF106/MF 110/MF 207/MF 306 OVENS ID 301 CLIMATIC TEST CABINET EN 055 / 120 & EN 400 / 500 INCUBATORS NB 9 / 20, BM 30, ST 30 & BS 30 WATER BATHS TK 120 / 252 / 600 TEST CABINETS NF 3000R HIGH CAPACITY REFRIGERATED BENCH TOP CENTRIFUGE NF 048 MICROLITER & HAEMATOCRIT CENTRIFUGE NF 200 SMALL CAPACITY BENCHTOP CENTRIFUGE NF 400 / NF 400R MEDIUM CAPACITY, NF 800 / NF 800R & NF 1200 NF 1200R MULTI PURPOSE BENCHTOP CENTRIFUGES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2025-11-17
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2025-11-17
JRM	Freezer	Clinical Chemistry	Class 1	862.2050	2025-11-17
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2025-11-17
QKH	Assisted Reproduction Laminar Flow Workstation	Obstetrics/Gynecology	Class 2	884.6120	2025-11-17
JRJ	Unit, Drying	Clinical Chemistry	Class 1	862.2050	2025-11-17
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2021-07-30
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2021-07-30

Official Correspondent

Yagmur Kocakir

US Agent Details

Kala Elumalai Business: MENVRAA - KPM (LLC) Email: 9342mdd@gmail.com Phone: (231) 2609191

Related Public Records

Same Entity

NUVE Sanayi Malzemeleri Imalat ve Ticaret A.S.

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 3019916040. Last updated year: 2026. Please use registration number 3019916040 when referencing this establishment in official correspondence.