MD Atlas update: Aug 5, 2026

Biochemical Diagnostics, Inc

US-MF-000025179

Active173 devices

Address: Heartland Blvd, 180 11717 Edgewood
Role: Manufacturer
Date of registration: Jun 17, 2022
Country: United States

Biochemical Diagnostics, Inc is a medical device manufacturer registered in EUDAMED. The company has 173 devices on the EU market across 32 countries. Headquartered in Edgewood, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About BCD

: US-MF-000025179
Role: Manufacturer
Country: United States
Organization name: Biochemical Diagnostics, Inc
EU VAT number: Not applicable
Date of registration: Jun 17, 2022

Contact details for BCD

Email: quality@biochemicaldiagnostics.com
Website: www.kovaintl.com
Address: 180, HEARTLAND BLVD HEARTLAND BLVD 11717 EDGEWOOD UNITED STATES

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Competent authority

Name: Malta Medicines Authority

Phone: +356 23439000
Email: devices.medicinesauthority@gov.mt

Officers and regulatory representatives of BCD

WALSH Amy
The conformity of the devices is correct in accordance with the QMS prior to release. - The technical documentation and DoC are drawn up and kept up to date. - The PMS obligations are complied with. - The reporting obligations are fulfilled.
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Connected operators

Importers

3 EU importers place this manufacturer's devices

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
9 PANEL -/+ 25%, 5ML KITBOX	9 PANEL -/+ 25%, 5ML KITBOX	`19002907`	`00810042680289`	1	On the market
9 PANEL, CUTOFF, 5mL	9 PANEL, CUTOFF, 5mL	`18002908`	`00810042680296`	1	On the market
AU/NZ SKREEN, Cutoff -50%, 20mL	AU/NZ SKREEN, Cutoff -50%, 20mL	`19481100`	`00850004812945`	1	On the market
AU/NZ SKREEN, Cutoff -50%, 5mL	AU/NZ SKREEN, Cutoff -50%, 5mL	`19480100`	`00850004812921`	1	On the market
AU/NZ SKREEN, Cutoff +50%, 20mL	AU/NZ SKREEN, Cutoff +50%, 20mL	`19482200`	`00850004812952`	1	On the market
AU/NZ SKREEN, Cutoff +50%, 5mL	AU/NZ SKREEN, Cutoff +50%, 5mL	`19480200`	`00850004812938`	1	On the market
AUNZS19 Cutoff -50%, 20mL	AUNZS19 Cutoff -50%, 20mL	`18100156`	`00810042682955`	1	On the market
AUNZS19 Cutoff -50%, 5mL	AUNZS19 Cutoff -50%, 5mL	`18100153`	`00810042681880`	1	On the market
AUNZS19 Cutoff +50%, 20mL	AUNZS19 Cutoff +50%, 20mL	`18100157`	`00810042682979`	1	On the market
AUNZS19 Cutoff +50%, 5mL	AUNZS19 Cutoff +50%, 5mL	`18100154`	`00810042682467`	1	On the market
Buprenorphine 15ng/mL, 5mL	Buprenorphine 15ng/mL, 5mL	`19470009`	`00810042681477`	1	On the market
Buprenorphine 5ng/mL, 5mL	Buprenorphine 5ng/mL, 5mL	`19470008`	`00810042681460`	1	On the market
Combo-A, 3X Cutoff, 20mL	Combo-A, 3X Cutoff, 20mL	`18003092`	`00810042682771`	1	On the market
Combo-A, 3X Cutoff, 6x20mL	Combo-A, 3X Cutoff, 6x20mL	`18003092-6pk`	`00850004812754`	1	On the market
Combo-A, Cutoff -50%, 20mL	Combo-A, Cutoff -50%, 20mL	`18003090`	`00810042682757`	1	On the market
Combo-A, Cutoff -50%, 6x20mL	Combo-A, Cutoff -50%, 6x20mL	`18003090-6pk`	`00850004812730`	1	On the market
Combo-A, Cutoff +50%, 20ml	Combo-A, Cutoff +50%, 20ml	`18003091`	`00810042682764`	1	On the market
Combo-A, Cutoff +50%, 6x20mL	Combo-A, Cutoff +50%, 6x20mL	`18003091-6pk`	`00850004812747`	1	On the market
Combo-H, +50%, 20ml	Combo-H, +50%, 20ml	`18002743`	`00810042680272`	1	On the market
Combo-H, 3X Cutoff, 20mL	Combo-H, 3X Cutoff, 20mL	`18002844`	`00810042682719`	1	On the market
Combo-H, 3X Cutoff, 6x20mL	Combo-H, 3X Cutoff, 6x20mL	`18002844-6pk`	`00850004812693`	1	On the market
Combo-H, Cutoff -50%, 20mL	Combo-H, Cutoff -50%, 20mL	`18002842`	`00810042682702`	1	On the market
Combo-H, Cutoff -50%, 6x20mL	Combo-H, Cutoff -50%, 6x20mL	`18002842-6pk`	`00850004812679`	1	On the market
Combo-H, Cutoff +50%, 6x20mL	Combo-H, Cutoff +50%, 6x20mL	`18002743-6pk`	`00850004812686`	1	On the market
Combo-U, 3X Cutoff, 20mL	Combo-U, 3X Cutoff, 20mL	`18003089`	`00810042682740`	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
9 PANEL -/+ 25%, 5ML KITBOX	9 PANEL -/+ 25%, 5ML KITBOX	`19002907`	`00810042680289`	1	On the market
9 PANEL, CUTOFF, 5mL	9 PANEL, CUTOFF, 5mL	`18002908`	`00810042680296`	1	On the market
AU/NZ SKREEN, Cutoff -50%, 20mL	AU/NZ SKREEN, Cutoff -50%, 20mL	`19481100`	`00850004812945`	1	On the market
AU/NZ SKREEN, Cutoff -50%, 5mL	AU/NZ SKREEN, Cutoff -50%, 5mL	`19480100`	`00850004812921`	1	On the market
AU/NZ SKREEN, Cutoff +50%, 20mL	AU/NZ SKREEN, Cutoff +50%, 20mL	`19482200`	`00850004812952`	1	On the market
AU/NZ SKREEN, Cutoff +50%, 5mL	AU/NZ SKREEN, Cutoff +50%, 5mL	`19480200`	`00850004812938`	1	On the market
AUNZS19 Cutoff -50%, 20mL	AUNZS19 Cutoff -50%, 20mL	`18100156`	`00810042682955`	1	On the market
AUNZS19 Cutoff -50%, 5mL	AUNZS19 Cutoff -50%, 5mL	`18100153`	`00810042681880`	1	On the market
AUNZS19 Cutoff +50%, 20mL	AUNZS19 Cutoff +50%, 20mL	`18100157`	`00810042682979`	1	On the market
AUNZS19 Cutoff +50%, 5mL	AUNZS19 Cutoff +50%, 5mL	`18100154`	`00810042682467`	1	On the market
Buprenorphine 15ng/mL, 5mL	Buprenorphine 15ng/mL, 5mL	`19470009`	`00810042681477`	1	On the market
Buprenorphine 5ng/mL, 5mL	Buprenorphine 5ng/mL, 5mL	`19470008`	`00810042681460`	1	On the market
Combo-A, 3X Cutoff, 20mL	Combo-A, 3X Cutoff, 20mL	`18003092`	`00810042682771`	1	On the market
Combo-A, 3X Cutoff, 6x20mL	Combo-A, 3X Cutoff, 6x20mL	`18003092-6pk`	`00850004812754`	1	On the market
Combo-A, Cutoff -50%, 20mL	Combo-A, Cutoff -50%, 20mL	`18003090`	`00810042682757`	1	On the market
Combo-A, Cutoff -50%, 6x20mL	Combo-A, Cutoff -50%, 6x20mL	`18003090-6pk`	`00850004812730`	1	On the market
Combo-A, Cutoff +50%, 20ml	Combo-A, Cutoff +50%, 20ml	`18003091`	`00810042682764`	1	On the market
Combo-A, Cutoff +50%, 6x20mL	Combo-A, Cutoff +50%, 6x20mL	`18003091-6pk`	`00850004812747`	1	On the market
Combo-H, +50%, 20ml	Combo-H, +50%, 20ml	`18002743`	`00810042680272`	1	On the market
Combo-H, 3X Cutoff, 20mL	Combo-H, 3X Cutoff, 20mL	`18002844`	`00810042682719`	1	On the market
Combo-H, 3X Cutoff, 6x20mL	Combo-H, 3X Cutoff, 6x20mL	`18002844-6pk`	`00850004812693`	1	On the market
Combo-H, Cutoff -50%, 20mL	Combo-H, Cutoff -50%, 20mL	`18002842`	`00810042682702`	1	On the market
Combo-H, Cutoff -50%, 6x20mL	Combo-H, Cutoff -50%, 6x20mL	`18002842-6pk`	`00850004812679`	1	On the market
Combo-H, Cutoff +50%, 6x20mL	Combo-H, Cutoff +50%, 6x20mL	`18002743-6pk`	`00850004812686`	1	On the market
Combo-U, 3X Cutoff, 20mL	Combo-U, 3X Cutoff, 20mL	`18003089`	`00810042682740`	1	On the market

Biochemical Diagnostics, Inc

About BCD

Contact details for BCD

Export the 173 devices of BCD

Competent authority

Officers and regulatory representatives of BCD

Connected operators

Importers

Related searches

About BCD

Contact details for BCD

Export the 173 devices of BCD

Competent authority

Officers and regulatory representatives of BCD

Statistics for BCD

Certificate health for BCD

Devices by risk class

Market presence of BCD

Device catalog for BCD

Device families (Basic UDI-DI) of BCD

Connected operators

Importers

Related searches

Market presence of BCD

Devices by risk class

Certificate health for BCD

Statistics for BCD

Device families (Basic UDI-DI) of BCD

Device catalog for BCD