MEDENTiKA E 30

by MEDENTiKA GmbH

Ref E 30Model Implant pick-up

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number42515748ABF0034N Basic UDI-DI 04251574811486UDI-DI	Date29 Jul 2026Registered	StatusActive
United States	GUDID listing GUDID	Number04251574811486 UDI-DI	Date8 Apr 2020Listed	StatusListed 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.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: MEDENTiKA
Generic Name: Dental implant suprastructure, temporary, preformed, reusable
Model / Ref / Catalog: E 30, Implant pick-up

Primary DI / UDI-DI: 04251574811486 EUDAMED
EMKAE309 GUDID
Basic UDI-DI: 42515748ABF0034N
FDA Product Code: NDP
EMDN Code: Q010599 Dental instruments, single-use - other
GMDN Term: Dental implant suprastructure, temporary, preformed, reusable

Device Class: Class I
Regulation Number: 872.3980
Market of Registration: Germany
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization
MRI Safety: MR Conditional

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED 04251574811486	GUDID EMKAE309
Implantable	EUDAMED No	GUDID Yes

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Properties

Single Use
Implantable NoEUDAMEDYesGUDID
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (19)

Sterile: 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
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No