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Aptus

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref A-6603.092

by Medartis Inc.

Identity

Trade Name
Screw Tray CCS 2.2, 3.0, Add-on General EUDAMED
APTUS FDA UDI
Generic Name
Device sterilization/disinfection container, reusable FDA UDI
Device Name
Container EUDAMED
Screw Tray CCS 2.2, 3.0, Add-on General FDA UDI
Model / Reference
A-6603.092 EUDAMEDFDA UDI
Description
Screw Tray CCS 2.2, 3.0, Add-on General FDA UDI

Identifiers

Catalog Number
A-6603.092 FDA UDI
Primary DI / UDI-DI
07630894811197 EUDAMEDFDA UDI
Basic UDI-DI
76300378000NY EUDAMED
510(k) Number
K232251 FDA UDI
FDA Product Code
HWC FDA UDI
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
GMDN Term
Device sterilization/disinfection container, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Market of Registration
Germany 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

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Device sterilization/disinfection container, reusable

Aptus by Medartis Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medartis Inc.

Sources (2)

  • FDA UDI d7fb0536-a3a9-43b6-bea6-c84e4f2ac40a 35 fields · synced Jul 13, 2026
  • EUDAMED 555b3e16-2afe-4807-b0a9-a4ace7c756fd 61 fields · synced Jul 13, 2026