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Aptimax™ Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 13826

by Advanced Sterilization Products, Inc.

Identity

Trade Name
Aptimax™ Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in) EUDAMED
Aptimax FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
APTIMAX™ Instrument Trays EUDAMED
Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in) FDA UDI
Model / Reference
13826 EUDAMEDFDA UDI
Description
Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in) FDA UDI

Identifiers

Catalog Number
13826 FDA UDI
Primary DI / UDI-DI
10705037016013 EUDAMEDFDA UDI
Basic UDI-DI
0705037A070000000000007RN EUDAMED
Direct Marketing DI
10705037016013 EUDAMED
510(k) Number
K013003 FDA UDI
FDA Product Code
FRG FDA UDI
EMDN Code
S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Market of Registration
Netherlands 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

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Aptimax™ Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in) by Advanced Sterilization Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED…

Manufacturer's product page: APTIMAX™ Instrument Trays

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Sterilization Products, Inc.
EUDAMED SRN
US-MF-000008427
Authorised Representative
ASP, The Netherlands B.V. NL-AR-000002057

Sources (3)

  • EUDAMED 9e22023e-7468-44bc-8913-4f1fb42ebebb 61 fields · synced Oct 6, 2026
  • FDA UDI 47444cb2-9f5d-4e06-99b7-279854dacb43 37 fields · synced May 29, 2026
  • EUDAMED 9ec93028-01c5-4af3-bc38-b017ce7ba22f 61 fields · synced Jul 15, 2026