EUDAMED update: Jul 24, 2026

Gyrus ACMI, Inc.

US-MF-000034237

Active20 devices

Address: Louisiana Ave. North, 9600 55445 Brooklyn Park, MN
Role: Manufacturer
Date of registration: Mar 15, 2023
Country: United States

Gyrus ACMI, Inc. is a medical device manufacturer registered in EUDAMED. The company has 20 devices on the EU market across 32 countries. Headquartered in Brooklyn Park, MN, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Gyrus ACMI, Inc.

: US-MF-000034237
Role: Manufacturer
Country: United States
Organization name: Gyrus ACMI, Inc.
EU VAT number: Not applicable
Date of registration: Mar 15, 2023

Contact details for Gyrus ACMI, Inc.

Email: osta-regulatoryaffairsrequests@olympus-osta.com
Address: 9600, LOUISIANA AVE. NORTH, 55445 BROOKLYN PARK, MN UNITED STATES

Competent authority

Name: DE/CA05 - Behorde fur Justiz und Verbraucherschutz

Phone: -
Email: medizinprodukte@justiz.hamburg.de

Officers and regulatory representatives of Gyrus ACMI, Inc.

VESTY Todd
Technical documentation, EU declaration of conformity, investigational devices
Hidden
JOPPRU Dave
Quality and conformity of the devices
Hidden
SHELLY Kimberly
Post-market surveillance (Article 10), Vigilance reporting (Articles 87-91)
Hidden

Connected operators

Importers

1 EU importer places this manufacturer's devices

Data export

Export the 20 devices of Gyrus ACMI, 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
DSD4000SA	—	`DSD4000SA`	`00821925044869`	5	On the market
SPL-W	—	`SPL-W`	`00821925039445`	1	On the market
HSDCK200	—	`HSDCK200`	`00821925035843`	1	On the market
MDFS100	—	`MDFS100`	`00821925027787`	1	On the market
EC3999	—	`EC3999`	`00821925011526`	1	On the market
PK-SP0533	—	`PK-SP0533`	`00821925041806`	1	On the market
DSD4000BA	—	`DSD4000BA`	`00821925044883`	5	On the market
LCFP100	—	`LCFP100`	`00821925040045`	1	On the market
PK-SP0533	—	`PK-SP0533`	`00821925028111`	5	On the market
DSD40MMSC	—	`DSD40MMSC`	`00821925045170`	5	On the market
MDHPTRAY	—	`MDHPTRAY`	`00821925027763`	1	On the market
3900	—	`3900`	`00821925010802`	1	On the market
SPL-NC	—	`SPL-NC`	`00821925043701`	1	On the market
HSDHP200TRAY	—	`HSDHP200TRAY`	`00821925035669`	1	On the market
SPL-CSL	—	`SPL-CSL`	`00821925043671`	1	On the market
HSDHP200TRAY	—	`HSDHP200TRAY`	`00821925035669`	1	On the market
MDFS100	—	`MDFS100`	`00821925027787`	1	On the market
DSDPP100	—	`DSDPP100`	`00821925044944`	1	On the market
DSD2000BA	—	`DSD2000BA`	`00821925044913`	5	On the market
HSDCK200	—	`HSDCK200`	`00821925035829`	5	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
DSD4000SA	—	`DSD4000SA`	`00821925044869`	5	On the market
SPL-W	—	`SPL-W`	`00821925039445`	1	On the market
HSDCK200	—	`HSDCK200`	`00821925035843`	1	On the market
MDFS100	—	`MDFS100`	`00821925027787`	1	On the market
EC3999	—	`EC3999`	`00821925011526`	1	On the market
PK-SP0533	—	`PK-SP0533`	`00821925041806`	1	On the market
DSD4000BA	—	`DSD4000BA`	`00821925044883`	5	On the market
LCFP100	—	`LCFP100`	`00821925040045`	1	On the market
PK-SP0533	—	`PK-SP0533`	`00821925028111`	5	On the market
DSD40MMSC	—	`DSD40MMSC`	`00821925045170`	5	On the market
MDHPTRAY	—	`MDHPTRAY`	`00821925027763`	1	On the market
3900	—	`3900`	`00821925010802`	1	On the market
SPL-NC	—	`SPL-NC`	`00821925043701`	1	On the market
HSDHP200TRAY	—	`HSDHP200TRAY`	`00821925035669`	1	On the market
SPL-CSL	—	`SPL-CSL`	`00821925043671`	1	On the market
HSDHP200TRAY	—	`HSDHP200TRAY`	`00821925035669`	1	On the market
MDFS100	—	`MDFS100`	`00821925027787`	1	On the market
DSDPP100	—	`DSDPP100`	`00821925044944`	1	On the market
DSD2000BA	—	`DSD2000BA`	`00821925044913`	5	On the market
HSDCK200	—	`HSDCK200`	`00821925035829`	5	On the market

Gyrus ACMI, Inc.

About Gyrus ACMI, Inc.

Contact details for Gyrus ACMI, Inc.

Competent authority

Officers and regulatory representatives of Gyrus ACMI, Inc.

Connected operators

Importers

Export the 20 devices of Gyrus ACMI, Inc.

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About Gyrus ACMI, Inc.

Contact details for Gyrus ACMI, Inc.

Competent authority

Officers and regulatory representatives of Gyrus ACMI, Inc.

Statistics for Gyrus ACMI, Inc.

Certificate health for Gyrus ACMI, Inc.

Related documents

Devices by risk class

Device catalog for Gyrus ACMI, Inc.

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

Market presence of Gyrus ACMI, Inc.

Connected operators

Importers

Export the 20 devices of Gyrus ACMI, Inc.

Related searches

Market presence of Gyrus ACMI, Inc.

Devices by risk class

Certificate health for Gyrus ACMI, Inc.

Statistics for Gyrus ACMI, Inc.

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

Related documents

Device catalog for Gyrus ACMI, Inc.