OT EQUATOR TITANIUM SCREW SELF-EXTRACTING SEEGER h3

by Rhein 83 SRL

Ref 158VAE

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

CE MDR

Valid until

2 Dec 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number805804571CSPLL Basic UDI-DI 08059224108865UDI-DI	Date18 Mar 2026Registered	StatusActive
European Union	CE/MDR EUDAMED	Number0425-MDR-030107-02	Date21 Jan 2026Issued	StatusActive expires 2 Dec 2029
United States	GUDID listing GUDID	Number08059224108865 UDI-DI	Date7 Jul 2025Listed	StatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

0425-MDR-030107-02 Active

Quality management system EU MDR

Certifier

ICIM S.P.A. 0425

Issued
21 Jan 2026

Expires
2 Dec 2029

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: VITE TITANIO h.3 SEEGER AUTOESTRAENTE EUDAMED
Ot Equator GUDID
Generic Name: Dental implant suprastructure, permanent, preformed
Device Name: Componenti per Protesi Fissa
Model / Ref / Catalog: 158VAE, TITANIUM SCREW SELF-EXTRACTING SEEGER h3

Primary DI / UDI-DI: 08059224108865
Basic UDI-DI: 805804571CSPLL
FDA Product Code: EJX
EMDN Code: Q010299 Prosthetic dentistry devices - other
GMDN Term: Dental implant suprastructure, permanent, preformed

Device Class: Class IIb EUDAMED
Class I GUDID
Regulation Number: 872.3130
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / Reference	EUDAMED 158VAE	GUDID TITANIUM SCREW SELF-EXTRACTING SEEGER h3
Device Class	EUDAMED Class IIb	GUDID Class I

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Properties

Single Use
Implantable
Sutures
Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (18)

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