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Straumann® ProClean™ Cassette (041.800 ; 041.801) Storage Systems / Cassettes

by Institut Straumann SA

Ref 041.813

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

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
European UnionCE/MDR EUDAMED Number0763003170029QS Basic UDI-DI 07630031779670UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630031779670 UDI-DI Date5 Aug 2026ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Straumann® ProClean™ Cassette (041.800 ; 041.801)
Generic Name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
041.813, Storage Systems / Cassettes
Primary DI / UDI-DI
07630031779670
Basic UDI-DI
0763003170029QS
510(k) Number
FDA Product Code
KCT
EMDN Code
S010499 Sterilisation containers - other
GMDN Term
Device sterilization/disinfection container, reusable
Models / Variants
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
041.813
GUDID
Storage Systems / Cassettes
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K260726)

Other devices from Institut Straumann SA

See all devices from Institut Straumann SA →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No