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Upper Eyelid Implant

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref 4007009510(k) K001123Ref 4007004Ref 4007010

by Heinz Kurz GmbH

Identity

Trade Name
Upper Eyelid Implant EUDAMED
Device Name
Upper Eyelid Implant EUDAMED
Model / Reference
4007009 EUDAMED
4007004 EUDAMED
4007010 EUDAMED

Identifiers

Primary DI / UDI-DI
14250368851094 EUDAMED
14250368851049 EUDAMED
14250368851100 EUDAMED
Basic UDI-DI
B-14250368851094 EUDAMED
B-14250368851049 EUDAMED
B-14250368851100 EUDAMED
510(k) Number
K001123 FDA 510(k)
FDA Product Code
MML FDA 510(k)
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5700 FDA 510(k)
Regulation Number
886.5700 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Upper Eyelid Implant by Heinz Kurz GmbH — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Heinz Kurz GmbH
EUDAMED SRN
DE-MF-000007959

Sources (4)

  • EUDAMED d2f73e32-3ec4-45d0-8b42-5016b3ca5cf8 61 fields · synced Oct 6, 2026
  • FDA 510(k) K001123 24 fields · synced May 18, 2026
  • EUDAMED a569eb9b-87fb-4819-9894-ee23e50de661 61 fields · synced Jul 13, 2026
  • EUDAMED 67b307bc-b820-4de0-9105-81022d3653d4 61 fields · synced Jul 14, 2026