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SURGmatic S201 XL Pro 1.013.7541

by KaVo Dental GmbH

Ref 1.013.7541

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

CE MDR

Valid until

28 Sep 2031

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification GmbH

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 Number51512-60-01-00 Date1 Sep 2026IssuedStatusActive expires 28 Sep 2031
United StatesGUDID listing GUDID NumberEKAV101375410 UDI-DI Date24 Jan 2020ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 51512-60-01-00 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification GmbH 0124
    Issued
    1 Sep 2026
    Expires
    28 Sep 2031
    Valid from
    29 Sep 2026

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  • Withdrawn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
SURGmatic S201 XL Pro
Generic Name
Dental power tool handpiece motorless component
Device Name
Dental straight and contra-angle handpieces
Model / Ref / Catalog
1.013.7541
Primary DI / UDI-DI
EKAV101375410
Basic UDI-DI
++EKAVG502Z5
510(k) Number
FDA Product Code
EBW
EMDN Code
Z12110102 Dental drills
GMDN Term
Dental power tool handpiece motorless component
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4200
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Dental power tool handpiece motorless component

Cleared under the same submission (K140308)

Show all (12)

Other devices from KaVo Dental GmbH

See all devices from KaVo Dental GmbH →

Properties

  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No