← Back to catalogue

microQuark

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref C09061-01-99

by COSMED Srl

Identity

Trade Name
microQuark EUDAMED
COSMED FDA UDI
Generic Name
Diagnostic spirometer, professional FDA UDI
Device Name
microQuark EUDAMED
The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation). FDA UDI
Model / Reference
C09061-01-99 EUDAMED
microQuark FDA UDI
Description
The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation). FDA UDI

Identifiers

Primary DI / UDI-DI
18052400180034 EUDAMEDFDA UDI
Basic UDI-DI
805240018mQSH EUDAMED
Direct Marketing DI
18052400180034 EUDAMED
510(k) Number
K020745 FDA UDI
FDA Product Code
BTY FDA UDI
BZC FDA UDI
EMDN Code
Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
GMDN Term
Diagnostic spirometer, professional FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
868.1890 FDA UDI
868.1880 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

microQuark by COSMED Srl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
COSMED Srl
EUDAMED SRN
IT-MF-000023488

Sources (3)

  • EUDAMED 02790967-ff55-49a4-9d96-ee216881c837 61 fields · synced Aug 2, 2026
  • FDA UDI bee00ccf-962e-43cf-a8bc-338c819d5079 35 fields · synced May 30, 2026
  • FDA 510(k) K020745 1 fields · synced May 18, 2026