EUDAMED update: Dec 12, 2025

NanoEntek, Inc.

KR-MF-000021903

Active69 devices

Address: Seohae-ro, 851-14 18531 Hwaseong-si
Role: Manufacturer
Date of registration: Mar 23, 2022
Country: South Korea

NanoEntek, Inc. is a medical device manufacturer registered in EUDAMED. The company has 69 devices on the EU market across 22 countries. Headquartered in Hwaseong-si, South Korea. Explore the regulatory profile, devices and certificates on MD Atlas.

About NanoEntek, Inc.

: KR-MF-000021903
Role: Manufacturer
Country: South Korea
Organization name: NanoEntek, Inc.
EU VAT number: 229-81-08112
Date of registration: Mar 23, 2022

Contact details for NanoEntek, Inc.

Phone: +82 010 8785 7859
Email: eudamed@nanoentek.com
Website: http://www.nanoentek.com
Address: 851-14, SEOHAE-RO PALTAN-MYEON, HWASEONG-SI, GYEONGGI-DO, REPUBLIC OF KOREA 18531 HWASEONG-SI SOUTH KOREA

Competent authority

Name: DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz

Phone: +49 6818500-0
Email: koordination_marktueberwachung@lua.saarland.de

Officers and regulatory representatives of NanoEntek, Inc.

JEONG Jason
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Connected operators

Importers

5 EU importers place this manufacturer's devices

Data export

Export the 69 devices of NanoEntek, Inc.

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
BioTracer™ Influenza A&B Test	BioTracer™ Influenza A&B Test	`11321`	`08809317540818`	1	On the market
FREND Cardiac Triple	FREND Cardiac Triple	`FRCT 025`	`08809317540078`	1	On the market
FREND Thyroid Duo	FREND Thyroid Duo	`FRTD 020`	`08809317540368`	1	On the market
ADAM-rWBC	ADAM-rWBC	`ADAM-rWBC`	`08809317540252`	1	On the market
ADAM-rWBC HT	ADAM-rWBC HT	`ADAM-rWBC HT`	`08809317540993`	1	On the market
ADAM-rWBC Kit	ADAM-rWBC Kit	`ADHK-050`	`08809317541006`	1	On the market
ADAM-rWBC Kit	ADAM-rWBC Kit	`AD1K-050`	`08809317540269`	1	On the market
ADAM-rWBC2	ADAM-rWBC2	`ADAM-rWBC2`	`08809317540498`	1	On the market
ADAMII	ADAMII	`ADAMII`	`08809317540627`	1	On the market
ADAMII-CD34 Kit	ADAMII-CD34 Kit	`CD34K-025`	`08809317540634`	1	On the market
ADAMII™-CD3/CD4/CD8 Kit	ADAMII™-CD3/CD4/CD8 Kit	`CD348K-025`	`08809317541020`	1	On the market
BioTracer™ Dengue Combo Rapid Card	BioTracer™ Dengue Combo Rapid Card	`17311`	`08809317541181`	1	On the market
BioTracer™ Dengue IgG/IgM Rapid Card	BioTracer™ Dengue IgG/IgM Rapid Card	`17112`	`08809317541167`	1	On the market
BioTracer™ Dengue NS1 Ag Rapid Card	BioTracer™ Dengue NS1 Ag Rapid Card	`17212`	`08809317541174`	1	On the market
BioTracer™ Influenza A&B Rapid Card	BioTracer™ Influenza A&B Rapid Card	`11311`	`08809317540801`	1	On the market
C-Chip	C-Chip	`DHC-N04`	`08809317540665`	1	On the market
C-Chip	C-Chip	`DHC-M01`	`08809317540603`	1	On the market
C-Chip	C-Chip	`DHC-N01`	`08809317540511`	1	On the market
C-Chip	C-Chip	`DHC-B04`	`08809317540689`	1	On the market
C-Chip	C-Chip	`DHC-B02`	`08809317540580`	1	On the market
C-Chip	C-Chip	`DHC-B01`	`08809317540573`	1	On the market
C-Chip	C-Chip	`DHC-F04`	`08809317540702`	1	On the market
C-Chip	C-Chip	`DHC-B0420`	`08809317540696`	1	On the market
C-Chip	C-Chip	`DHC-N0420`	`08809317540672`	1	On the market
C-Chip	C-Chip	`DHC-F0420`	`08809317540719`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
BioTracer™ Influenza A&B Test	BioTracer™ Influenza A&B Test	`11321`	`08809317540818`	1	On the market
FREND Cardiac Triple	FREND Cardiac Triple	`FRCT 025`	`08809317540078`	1	On the market
FREND Thyroid Duo	FREND Thyroid Duo	`FRTD 020`	`08809317540368`	1	On the market
ADAM-rWBC	ADAM-rWBC	`ADAM-rWBC`	`08809317540252`	1	On the market
ADAM-rWBC HT	ADAM-rWBC HT	`ADAM-rWBC HT`	`08809317540993`	1	On the market
ADAM-rWBC Kit	ADAM-rWBC Kit	`ADHK-050`	`08809317541006`	1	On the market
ADAM-rWBC Kit	ADAM-rWBC Kit	`AD1K-050`	`08809317540269`	1	On the market
ADAM-rWBC2	ADAM-rWBC2	`ADAM-rWBC2`	`08809317540498`	1	On the market
ADAMII	ADAMII	`ADAMII`	`08809317540627`	1	On the market
ADAMII-CD34 Kit	ADAMII-CD34 Kit	`CD34K-025`	`08809317540634`	1	On the market
ADAMII™-CD3/CD4/CD8 Kit	ADAMII™-CD3/CD4/CD8 Kit	`CD348K-025`	`08809317541020`	1	On the market
BioTracer™ Dengue Combo Rapid Card	BioTracer™ Dengue Combo Rapid Card	`17311`	`08809317541181`	1	On the market
BioTracer™ Dengue IgG/IgM Rapid Card	BioTracer™ Dengue IgG/IgM Rapid Card	`17112`	`08809317541167`	1	On the market
BioTracer™ Dengue NS1 Ag Rapid Card	BioTracer™ Dengue NS1 Ag Rapid Card	`17212`	`08809317541174`	1	On the market
BioTracer™ Influenza A&B Rapid Card	BioTracer™ Influenza A&B Rapid Card	`11311`	`08809317540801`	1	On the market
C-Chip	C-Chip	`DHC-N04`	`08809317540665`	1	On the market
C-Chip	C-Chip	`DHC-M01`	`08809317540603`	1	On the market
C-Chip	C-Chip	`DHC-N01`	`08809317540511`	1	On the market
C-Chip	C-Chip	`DHC-B04`	`08809317540689`	1	On the market
C-Chip	C-Chip	`DHC-B02`	`08809317540580`	1	On the market
C-Chip	C-Chip	`DHC-B01`	`08809317540573`	1	On the market
C-Chip	C-Chip	`DHC-F04`	`08809317540702`	1	On the market
C-Chip	C-Chip	`DHC-B0420`	`08809317540696`	1	On the market
C-Chip	C-Chip	`DHC-N0420`	`08809317540672`	1	On the market
C-Chip	C-Chip	`DHC-F0420`	`08809317540719`	1	On the market

NanoEntek, Inc.

About NanoEntek, Inc.

Contact details for NanoEntek, Inc.

Competent authority

Officers and regulatory representatives of NanoEntek, Inc.

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Importers

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About NanoEntek, Inc.

Contact details for NanoEntek, Inc.

Competent authority

Officers and regulatory representatives of NanoEntek, Inc.

Statistics for NanoEntek, Inc.

Certificate health for NanoEntek, Inc.

Related documents

Devices by risk class

Device catalog for NanoEntek, Inc.

Device families (Basic UDI-DI) of NanoEntek, Inc.

Market presence of NanoEntek, Inc.

Connected operators

Importers

Export the 69 devices of NanoEntek, Inc.

Related searches

Certificate health for NanoEntek, Inc.

Statistics for NanoEntek, Inc.

Market presence of NanoEntek, Inc.

Devices by risk class

Related documents

Device families (Basic UDI-DI) of NanoEntek, Inc.

Device catalog for NanoEntek, Inc.