EUDAMED update: Jan 30, 2024

MAUNA KEA TECHNOLOGIES

FR-MF-000000835

Active20 devices

Address: Rue d'Enghien, 9 75010 Paris
Role: Manufacturer
Date of registration: Jan 20, 2021
Country: France

MAUNA KEA TECHNOLOGIES is a medical device manufacturer registered in EUDAMED. The company has 20 devices on the EU market across 10 countries. It holds 1 valid CE certificate. Headquartered in Paris, France. Explore the regulatory profile, devices and certificates on MD Atlas.

About MAUNA KEA TECHNOLOGIES

: FR-MF-000000835
Role: Manufacturer
Country: France
Organization name: MAUNA KEA TECHNOLOGIES
EU VAT number: FR54431268028
Founded: Apr 21, 2000

Contact details for MAUNA KEA TECHNOLOGIES

Email: ra@maunakeatech.com
Address: 9, RUE D'ENGHIEN 75010 PARIS FRANCE

Data export

Export the 20 devices of MAUNA KEA TECHNOLOGIES

Get the catalogue in Excel or CSV format — trade name, product reference, UDI and EMDN codes, legislation, quantity, last update, and more. The exact row count and price are confirmed before you pay.

Learn more about exports

Competent authority

Name: Agence Nationale de Sécurité du Médicament et des Produits de Santé

Phone: + 33 (1) 5587 3000
Email: contact.eudamed@ansm.sante.fr

Officers and regulatory representatives of MAUNA KEA TECHNOLOGIES

SÉBASTIEN Andrea
- S'assurer que la documentation technique et la déclaration de conformité UE soient établies et tenues à jour - S'assurer que les obligations en matière de surveillance après commercialisation soient remplies ainsi que les obligations en matière de notification (report des incidents, notification des autorités de santé). - Pour les dispositifs faisant l'objet d'une investigation, s'assurer que la déclaration visée à l'annexe XV, chapitre II du MDR soit délivrée.
Hidden
PRADES Emmanuel
Toutes les attributions visées au paragraphe 3 de l'article 15 du Règlement (UE) 2017/745
Hidden

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
AlveoFlex™ N	AlveoFlex™ N	`FP-10029`	`03760187912011`	1	On the market
AlveoFlex™N	AlveoFlex™N	`FP-10029`	`03760187912011`	1	On the market
AQ-Flex™ 19 N	AQ-Flex™ 19 N	`FP-10033`	`03760187912059`	1	On the market
AQ-Flex™ 19 N	AQ-Flex™ 19 N	`FP-10033`	`03760187912059`	1	On the market
CelioFlex ™ 5 N	CelioFlex ™ 5 N	`FP-10036`	`03760187912080`	1	On the market
CelioFlex ™ 5 N	CelioFlex ™ 5 N	`FP-10036`	`03760187912080`	1	On the market
Cellvizio® I.V.E.	Cellvizio® I.V.E.	`FP-10001`	`03760187912004`	1	On the market
Cellvizio® I.V.E.	Cellvizio® I.V.E.	`FP-10001`	`03760187912004`	1	On the market
CholangioFlex™ N	CholangioFlex™ N	`FP-10035`	`03760187912073`	1	On the market
CholangioFlex™ N	CholangioFlex™ N	`FP-10035`	`03760187912073`	1	On the market
ColoFlex™N	ColoFlex™N	`FP-10031`	`03760187912035`	1	On the market
ColoFlex™N	ColoFlex™N	`FP-10031`	`03760187912035`	1	On the market
CystoFlex™ F N	CystoFlex™ F N	`FP-10038`	`03760187912103`	1	On the market
CystoFlex™ F N	CystoFlex™ F N	`FP-10038`	`03760187912103`	1	On the market
CystoFlex™ R N	CystoFlex™ R N	`FP-10032`	`03760187912042`	1	On the market
CystoFlex™R N	CystoFlex™R N	`FP-10032`	`03760187912042`	1	On the market
GastroFlex™ N	GastroFlex™ N	`FP-10030`	`03760187912028`	1	On the market
GastroFlex™ N	GastroFlex™ N	`FP-10030`	`03760187912028`	1	On the market
UroFlex™ N	UroFlex™ N	`FP-10037`	`03760187912097`	1	On the market
UroFlex™ N	UroFlex™ N	`FP-10037`	`03760187912097`	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
AlveoFlex™ N	AlveoFlex™ N	`FP-10029`	`03760187912011`	1	On the market
AlveoFlex™N	AlveoFlex™N	`FP-10029`	`03760187912011`	1	On the market
AQ-Flex™ 19 N	AQ-Flex™ 19 N	`FP-10033`	`03760187912059`	1	On the market
AQ-Flex™ 19 N	AQ-Flex™ 19 N	`FP-10033`	`03760187912059`	1	On the market
CelioFlex ™ 5 N	CelioFlex ™ 5 N	`FP-10036`	`03760187912080`	1	On the market
CelioFlex ™ 5 N	CelioFlex ™ 5 N	`FP-10036`	`03760187912080`	1	On the market
Cellvizio® I.V.E.	Cellvizio® I.V.E.	`FP-10001`	`03760187912004`	1	On the market
Cellvizio® I.V.E.	Cellvizio® I.V.E.	`FP-10001`	`03760187912004`	1	On the market
CholangioFlex™ N	CholangioFlex™ N	`FP-10035`	`03760187912073`	1	On the market
CholangioFlex™ N	CholangioFlex™ N	`FP-10035`	`03760187912073`	1	On the market
ColoFlex™N	ColoFlex™N	`FP-10031`	`03760187912035`	1	On the market
ColoFlex™N	ColoFlex™N	`FP-10031`	`03760187912035`	1	On the market
CystoFlex™ F N	CystoFlex™ F N	`FP-10038`	`03760187912103`	1	On the market
CystoFlex™ F N	CystoFlex™ F N	`FP-10038`	`03760187912103`	1	On the market
CystoFlex™ R N	CystoFlex™ R N	`FP-10032`	`03760187912042`	1	On the market
CystoFlex™R N	CystoFlex™R N	`FP-10032`	`03760187912042`	1	On the market
GastroFlex™ N	GastroFlex™ N	`FP-10030`	`03760187912028`	1	On the market
GastroFlex™ N	GastroFlex™ N	`FP-10030`	`03760187912028`	1	On the market
UroFlex™ N	UroFlex™ N	`FP-10037`	`03760187912097`	1	On the market
UroFlex™ N	UroFlex™ N	`FP-10037`	`03760187912097`	1	On the market

MAUNA KEA TECHNOLOGIES

About MAUNA KEA TECHNOLOGIES

Contact details for MAUNA KEA TECHNOLOGIES

Export the 20 devices of MAUNA KEA TECHNOLOGIES

Competent authority

Officers and regulatory representatives of MAUNA KEA TECHNOLOGIES

Related searches

About MAUNA KEA TECHNOLOGIES

Contact details for MAUNA KEA TECHNOLOGIES

Export the 20 devices of MAUNA KEA TECHNOLOGIES

Competent authority

Officers and regulatory representatives of MAUNA KEA TECHNOLOGIES

Statistics for MAUNA KEA TECHNOLOGIES

Certificate health for MAUNA KEA TECHNOLOGIES

Related documents

Devices by risk class

Market presence of MAUNA KEA TECHNOLOGIES

Device catalog for MAUNA KEA TECHNOLOGIES

Device families (Basic UDI-DI) of MAUNA KEA TECHNOLOGIES

Related searches

Market presence of MAUNA KEA TECHNOLOGIES

Devices by risk class

Related documents

Device families (Basic UDI-DI) of MAUNA KEA TECHNOLOGIES

Statistics for MAUNA KEA TECHNOLOGIES

Certificate health for MAUNA KEA TECHNOLOGIES

Device catalog for MAUNA KEA TECHNOLOGIES