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Mectascope 05.17.10.0002

by Medacta International SA

Ref 05.17.10.0002Model Sportsmed Optical system (Scope)

Mectascope 05.17.10.0002 is a device classified as Class IIa in the EU and Class II in the US made by Medacta International SA, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI 764014274LSR0212N00BA), cleared under FDA 510(k) K200067 on 1 Oct 2020 and listed in FDA GUDID since 6 Oct 2020 (UDI-DI 07630040733519), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200067

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274LSR0212N00BA Basic UDI-DI 07630040733519UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040733519 UDI-DI Date6 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200067 Date1 Oct 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764014274LSR0212N00BA registered 16 Jul 2026 Active
  • FDA 510(k) K200067 decided 1 Oct 2020 Active
  • FDA GUDID UDI-DI 07630040733519 listed 6 Oct 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200067
  2. Listed FDA GUDID 07630040733519
  3. Registered EUDAMED 764014274LSR0212N00BA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MectaScope - Scope 70°, Ø4 L=18cm Autoclavable HD EUDAMED
Mectascope GUDID
Generic name
Rigid endoscope telescope
Model / reference
05.17.10.0002, Sportsmed Optical system (Scope)
Primary DI / UDI-DI
07630040733519
Basic UDI-DI
764014274LSR0212N00BA
Direct marketing DI
07630040733519
510(k) Number
FDA product code
HRX
EMDN code
Z12021101 Arthroscopes
GMDN term
Rigid endoscope telescope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.1100
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07630040733519: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Rigid endoscope telescope

Cleared under the same submission (K200067)

Similar devices in this category

Other devices filed under ARTHROSCOPES.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)