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Microtek

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 3827

by Microtek Medical LLC

Identity

Trade Name
Microtek EUDAMEDFDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
Probe Covers EUDAMED
GENERAL PURPOSE PROBE COVER, 7 X 72, 1-EACH FDA UDI
Model / Reference
3827 EUDAMED
1 FDA UDI
Description
GENERAL PURPOSE PROBE COVER, 7 X 72, 1-EACH FDA UDI

Identifiers

Primary DI / UDI-DI
00748426010806 EUDAMEDFDA UDI
Basic UDI-DI
0748426MI2APC23INE2AN EUDAMED
510(k) Number
K882724 FDA UDI
FDA Product Code
KKX FDA UDI
EMDN Code
T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
GMDN Term
Body-surface ultrasound imaging transducer cover FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Microtek by Microtek Medical LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microtek Medical LLC
EUDAMED SRN
US-MF-000019222
Authorised Representative
Microtek Medical B.V. NL-AR-000006076

Sources (2)

  • EUDAMED 3478755c-dccb-4f43-8303-72b5534bff33 61 fields · synced Jul 9, 2026
  • FDA UDI c8ce49a7-5b2f-4c7b-9ab8-7087854f7333 36 fields · synced May 30, 2026