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ProTekt PG 44620MU

by Diamatrix

Ref PG 44620MU

ProTekt PG 44620MU is a Class I device made by Diamatrix, registered in EUDAMED on 5 Jun 2025 (Basic UDI-DI B-00813059011893) and listed in FDA GUDID since 24 Oct 2019 (UDI-DI 00813059011893), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813059011893 Basic UDI-DI 00813059011893UDI-DIDate5 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00813059011893 UDI-DI Date24 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00813059011893 registered 5 Jun 2025 Active
  • FDA GUDID UDI-DI 00813059011893 listed 24 Oct 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813059011893
  2. Registered EUDAMED B-00813059011893

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ProTekt
Generic name
Ophthalmic knife, reusable
Device name
ProTekt Slit Knife, 2.2mm, Double Bevel, Angled, Box of 6, Multi-Use
Model / reference
PG 44620MU
Description
ProTekt Slit Knife, 2.2mm, Double Bevel, Angled, Multi-Use
Primary DI / UDI-DI
00813059011893
Basic UDI-DI
B-00813059011893
FDA product code
HNN
EMDN code
Q02010102 Ophthalmic microknives, angled
GMDN term
Ophthalmic knife, reusable
Device class
Class I
Regulation number
886.4350
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Sterilise before use UDI-DI 00813059011893: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Ophthalmic knife, reusable

Similar devices in this category

Other devices filed under OPHTHALMIC MICROKNIVES, ANGLED.

Other devices from Diamatrix

See all devices from Diamatrix →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)