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Case Medical Inc. CMAX100

by Case Medical Inc

Ref CMAX100Model SteriTite

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00653159013249 UDI-DI Date11 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0653159SC0004SAR Basic UDI-DI 00653159013249UDI-DIDate29 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
CMAX100 EUDAMED
Case Medical Inc. GUDID
Generic Name
Device sterilization/disinfection container, reusable
Device Name
9736523
Model / Ref / Catalog
CMAX100, SteriTite
Primary DI / UDI-DI
00653159013249
Basic UDI-DI
0653159SC0004SAR
Direct Marketing DI
00653159013249
FDA Product Code
KCT
EMDN Code
S010499 Sterilisation containers - other
GMDN Term
Device sterilization/disinfection container, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Case Medical Inc

See all devices from Case Medical Inc →

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No